A Dose Ranging Study Of PF-00868554 In Combination With PEGASYS And COPEGUS In Patients With Chronic Hepatitis C Genotype 1 Infection
Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00720434
Collaborator
(none)
35
10
4
19
3.5
0.2
Study Details
Study Description
Brief Summary
The purpose of this study is to further assess the potency of PF-00868554, an HCV polymerase inhibitor, in subjects chronically infected with HCV by evaluating the antiviral activity of PF-00868554 in combination with current standard of care therapy, pegylated interferon-alpha2a (PEGASYS) and ribavirin (COPEGUS).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
35 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Phase 2, Randomized, Placebo Controlled, Dose Ranging Study To Evaluate Peginterferon Alfa 2a (Pegasys®) And Ribavirin (Copegus®) With And Without PF-00868554 In Subjects Chronically Infected With Hepatitis C Virus
Study Start Date
:
Aug 1, 2008
Actual Primary Completion Date
:
Mar 1, 2010
Actual Study Completion Date
:
Mar 1, 2010
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: A 500 mg BID |
Drug: PF-00868554
500 mg BID administered as 5x100 mg tablets for 4 weeks in combination with standard of care; standard of care continued for an additional 44 weeks.
|
| Experimental: B 300 mg BID |
Drug: PF-00868554
300 mg BID administered as 3x100 mg tablets for 4 weeks in combination with standard of care; standard of care continued for an additional 44 weeks
|
| Experimental: C 200 mg BID |
Drug: PF-00868554
200 mg BID administered as 2x100 mg tablets for 4 weeks in combination with standard of care; standard of care continued for an additional 44 weeks
|
| Placebo Comparator: D Placebo |
Drug: Placebo
Placebo administered for 4 weeks in combination with standard of care; standard of care continued for an additional 44 weeks
|
Outcome Measures
Primary Outcome Measures
- Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 4 - Full Analysis Set [Baseline, Week 4]
Plasma HCV RNA levels were measured using the Roche COBAS Taqman assay (limit of detection: 25 international unit per milliliter [IU/mL]). Baseline value calculated as the average of the screening and Day 1 pre-dose measurements.
- Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 4 - Modified Analysis Set [Baseline, Week 4]
Plasma HCV RNA levels were measured using the Roche COBAS Taqman assay (limit of detection: 25 IU/mL). Baseline value calculated as the average of the screening and Day 1 pre-dose measurements.
Secondary Outcome Measures
- Proportion of Participants Achieving Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) [Week 4, 12, 48, 60, 72]
Proportion of participants achieving undetectable plasma HCV RNA at Week 4 (rapid virologic response), at Week 12 (early virologic response), at Week 48 (end of treatment response), at Week 60 (sustained virologic response; 12 weeks after cessation of therapy), at Week 72 (sustained virologic response; 24 weeks after cessation of therapy) were summarized. Undetectable viral load was defined as HCV RNA <25 IU/mL.
- Alanine Aminotransferase (ALT) Levels [Week 4, 12, 48, 72]
- Population Pharmacokinetics (PK) of PF-00868554 [1, 2 and 6 hours post-dose on Day 1; 0 hour (pre-dose) on Day 7, 14, 21; 0 hour (pre-dose), 2, 6 hours post-dose on Day 28]
Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Treatment naive (no prior treatment with IFN-a +/- RBV regimens.
-
Subjects who have discontinued IFN-a containing regimens after <2 weeks of therapy due to tolerability issues are considered treatment naive.
-
HCV RNA > 100,000 IU/mL at screening.
-
Genotype 1.
-
A diagnosis of chronic HCV infection for at least 6 months.
Exclusion Criteria:
-
Evidence of acute or chronic infection with HIV or HBV.
-
Exposure within the previous three months to an investigational anti-HCV agent.
-
Evidence of severe or decompensated liver disease.
-
Subjects with liver disease unrelated to HCV infection.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pfizer Investigational Site | La Jolla | California | United States | 92037 |
| 2 | Pfizer Investigational Site | San Francisco | California | United States | 94115 |
| 3 | Pfizer Investigational Site | Orlando | Florida | United States | 32803 |
| 4 | Pfizer Investigational Site | Springfield | Massachusetts | United States | 01107 |
| 5 | Pfizer Investigational Site | New York | New York | United States | 10021 |
| 6 | Pfizer Investigational Site | New York | New York | United States | 10065 |
| 7 | Pfizer Investigational Site | Tulsa | Oklahoma | United States | 74135 |
| 8 | Pfizer Investigational Site | Nashville | Tennessee | United States | 37205 |
| 9 | Pfizer Investigational Site | San Antonio | Texas | United States | 78215 |
| 10 | Pfizer Investigational Site | Santurce | Puerto Rico | 00909 |
Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT00720434
Other Study ID Numbers:
- A8121007
First Posted:
Jul 22, 2008
Last Update Posted:
Aug 26, 2013
Last Verified:
Jun 1, 2013
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | PF-00868554 200 mg + pegIFN Alfa-2a/RBV | PF-00868554 300 mg + pegIFN Alfa-2a/RBV | PF-00868554 500 mg + pegIFN Alfa-2a/RBV | Placebo + pegIFN Alfa-2a/RBV |
|---|---|---|---|---|
| Arm/Group Description | PF-00868554 200 milligram (mg) (2 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegylated interferon alfa-2a (pegIFN alfa-2a) 180 microgram (mcg) subcutaneously once weekly starting from Day 1 and ribavirin (RBV) 1000 mg/day tablet orally in 2 divided doses for participants weighing less than or equal to (<=) 75 kilogram (kg); 1200 mg/day orally in 2 divided doses for participants weighing greater than (>) 75 kg. | PF-00868554 300 mg (3 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg. | PF-00868554 500 mg (5 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg. | Placebo matched to PF-00868554 tablets orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg. |
| Period Title: Double-Blind Period (Week 1-4) | ||||
| STARTED | 10 | 9 | 8 | 8 |
| COMPLETED | 10 | 8 | 8 | 8 |
| NOT COMPLETED | 0 | 1 | 0 | 0 |
| Period Title: Double-Blind Period (Week 1-4) | ||||
| STARTED | 10 | 8 | 8 | 8 |
| COMPLETED | 4 | 5 | 4 | 4 |
| NOT COMPLETED | 6 | 3 | 4 | 4 |
Baseline Characteristics
| Arm/Group Title | PF-00868554 200 mg + pegIFN Alfa-2a/RBV | PF-00868554 300 mg + pegIFN Alfa-2a/RBV | PF-00868554 500 mg + pegIFN Alfa-2a/RBV | Placebo + pegIFN Alfa-2a/RBV | Total |
|---|---|---|---|---|---|
| Arm/Group Description | PF-00868554 200 milligram (mg) (2 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegylated interferon alfa-2a (pegIFN alfa-2a) 180 microgram (mcg) subcutaneously once weekly starting from Day 1 and ribavirin (RBV) 1000 mg/day tablet orally in 2 divided doses for participants weighing less than or equal to (<=) 75 kilogram (kg); 1200 mg/day orally in 2 divided doses for participants weighing greater than (>) 75 kg. | PF-00868554 300 mg (3 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg. | PF-00868554 500 mg (5 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg. | Placebo matched to PF-00868554 tablets orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg. | Total of all reporting groups |
| Overall Participants | 10 | 9 | 8 | 8 | 35 |
| Age, Customized (participants) [Number] | |||||
| 18 to 44 years |
5
50%
|
3
33.3%
|
3
37.5%
|
1
12.5%
|
12
34.3%
|
| 45 to 64 years |
5
50%
|
6
66.7%
|
5
62.5%
|
7
87.5%
|
23
65.7%
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
3
30%
|
7
77.8%
|
2
25%
|
5
62.5%
|
17
48.6%
|
| Male |
7
70%
|
2
22.2%
|
6
75%
|
3
37.5%
|
18
51.4%
|
Outcome Measures
| Title | Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 4 - Full Analysis Set |
|---|---|
| Description | Plasma HCV RNA levels were measured using the Roche COBAS Taqman assay (limit of detection: 25 international unit per milliliter [IU/mL]). Baseline value calculated as the average of the screening and Day 1 pre-dose measurements. |
| Time Frame | Baseline, Week 4 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of study drug and had both baseline and at least 1 valid post-baseline endpoint measurements for HCV viral load. Here 'n' signifies participants evaluable for this measure at specified time points for each arm, respectively. |
| Arm/Group Title | PF-00868554 200 mg + pegIFN Alfa-2a/RBV | PF-00868554 300 mg + pegIFN Alfa-2a/RBV | PF-00868554 500 mg + pegIFN Alfa-2a/RBV | Placebo + pegIFN Alfa-2a/RBV |
|---|---|---|---|---|
| Arm/Group Description | PF-00868554 200 milligram (mg) (2 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegylated interferon alfa-2a (pegIFN alfa-2a) 180 microgram (mcg) subcutaneously once weekly starting from Day 1 and ribavirin (RBV) 1000 mg/day tablet orally in 2 divided doses for participants weighing less than or equal to (<=) 75 kilogram (kg); 1200 mg/day orally in 2 divided doses for participants weighing greater than (>) 75 kg. | PF-00868554 300 mg (3 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg. | PF-00868554 500 mg (5 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg. | Placebo matched to PF-00868554 tablets orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg. |
| Measure Participants | 10 | 9 | 8 | 8 |
| Baseline (n=10, 9, 8, 8) |
6.38843
(0.483283)
|
6.67823
(0.472198)
|
6.66254
(0.563548)
|
6.42047
(0.499677)
|
| Change at Week 4 (n=10, 8, 8, 8) |
-4.45887
(1.422134)
|
-4.64646
(1.982243)
|
-3.61918
(2.488935)
|
-2.10239
(1.429056)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | PF-00868554 200 mg + pegIFN Alfa-2a/RBV, Placebo + pegIFN Alfa-2a/RBV |
|---|---|---|
| Comments | An analysis of covariance (ANCOVA) model was used to compare differences among treatments. Independent variables included treatment and log-transformed baseline HCV viral load. Adjusted mean difference and corresponding 95 percentage (%) confidence interval (CI) were calculated. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0131 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Adjusted Mean Difference |
| Estimated Value | -2.36357 | |
| Confidence Interval |
(2-Sided) 95% -4.19228 to -0.53485 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | PF-00868554 300 mg + pegIFN Alfa-2a/RBV, Placebo + pegIFN Alfa-2a/RBV |
|---|---|---|
| Comments | An ANCOVA model was used to compare differences among treatments. Independent variables included treatment and log-transformed baseline HCV viral load. Adjusted mean difference and corresponding 95% CI were calculated. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0142 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Adjusted Mean Difference |
| Estimated Value | -2.49190 | |
| Confidence Interval |
(2-Sided) 95% -4.44619 to -0.53760 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | PF-00868554 500 mg + pegIFN Alfa-2a/RBV, Placebo + pegIFN Alfa-2a/RBV |
|---|---|---|
| Comments | An ANCOVA model was used to compare differences among treatments. Independent variables included treatment and log-transformed baseline HCV viral load. Adjusted mean difference and corresponding 95% CI were calculated. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1368 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Adjusted Mean Difference |
| Estimated Value | -1.46325 | |
| Confidence Interval |
(2-Sided) 95% -3.41898 to 0.49248 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | PF-00868554 200 mg + pegIFN Alfa-2a/RBV, PF-00868554 500 mg + pegIFN Alfa-2a/RBV |
|---|---|---|
| Comments | An ANCOVA model was used to compare differences among treatments. Independent variables included treatment and log-transformed baseline HCV viral load. Adjusted mean difference and corresponding 95% CI were calculated. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3321 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Adjusted Mean Difference |
| Estimated Value | -0.90032 | |
| Confidence Interval |
(2-Sided) 95% -2.76711 to 0.96648 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | PF-00868554 300 mg + pegIFN Alfa-2a/RBV, PF-00868554 500 mg + pegIFN Alfa-2a/RBV |
|---|---|---|
| Comments | An ANCOVA model was used to compare differences among treatments. Independent variables included treatment and log-transformed baseline HCV viral load. Adjusted mean difference and corresponding 95% CI were calculated. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2839 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Adjusted Mean Difference |
| Estimated Value | -1.02865 | |
| Confidence Interval |
(2-Sided) 95% -2.95573 to 0.89844 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | PF-00868554 200 mg + pegIFN Alfa-2a/RBV, PF-00868554 300 mg + pegIFN Alfa-2a/RBV |
|---|---|---|
| Comments | An ANCOVA model was used to compare differences among treatments. Independent variables included treatment and log-transformed baseline HCV viral load. Adjusted mean difference and corresponding 95% CI were calculated. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8891 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Adjusted Mean Difference |
| Estimated Value | 0.12833 | |
| Confidence Interval |
(2-Sided) 95% -1.73676 to 1.99342 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Proportion of Participants Achieving Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) |
|---|---|
| Description | Proportion of participants achieving undetectable plasma HCV RNA at Week 4 (rapid virologic response), at Week 12 (early virologic response), at Week 48 (end of treatment response), at Week 60 (sustained virologic response; 12 weeks after cessation of therapy), at Week 72 (sustained virologic response; 24 weeks after cessation of therapy) were summarized. Undetectable viral load was defined as HCV RNA <25 IU/mL. |
| Time Frame | Week 4, 12, 48, 60, 72 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Modified Analysis Set: subset of FAS that included all participants who completed the Week 4 visit. |
| Arm/Group Title | PF-00868554 200 mg + pegIFN Alfa-2a/RBV | PF-00868554 300 mg + pegIFN Alfa-2a/RBV | PF-00868554 500 mg + pegIFN Alfa-2a/RBV | Placebo + pegIFN Alfa-2a/RBV |
|---|---|---|---|---|
| Arm/Group Description | PF-00868554 200 milligram (mg) (2 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegylated interferon alfa-2a (pegIFN alfa-2a) 180 microgram (mcg) subcutaneously once weekly starting from Day 1 and ribavirin (RBV) 1000 mg/day tablet orally in 2 divided doses for participants weighing less than or equal to (<=) 75 kilogram (kg); 1200 mg/day orally in 2 divided doses for participants weighing greater than (>) 75 kg. | PF-00868554 300 mg (3 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg. | PF-00868554 500 mg (5 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg. | Placebo matched to PF-00868554 tablets orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg. |
| Measure Participants | 10 | 8 | 8 | 8 |
| Week 4 |
0.6000
6%
|
0.7500
8.3%
|
0.6250
7.8%
|
0.0000
0%
|
| Week 12 |
0.8000
8%
|
0.8750
9.7%
|
0.6250
7.8%
|
0.5000
6.3%
|
| Week 48 |
0.6000
6%
|
0.7500
8.3%
|
0.6250
7.8%
|
0.5000
6.3%
|
| Week 60 |
0.3000
3%
|
0.5000
5.6%
|
0.5000
6.3%
|
0.5000
6.3%
|
| Week 72 |
0.3000
3%
|
0.5000
5.6%
|
0.5000
6.3%
|
0.5000
6.3%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | PF-00868554 200 mg + pegIFN Alfa-2a/RBV, Placebo + pegIFN Alfa-2a/RBV |
|---|---|---|
| Comments | Week 4: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in Proportions |
| Estimated Value | 0.6000 | |
| Confidence Interval |
(2-Sided) 95% 0.1565 to 0.8785 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | PF-00868554 300 mg + pegIFN Alfa-2a/RBV, Placebo + pegIFN Alfa-2a/RBV |
|---|---|---|
| Comments | Week 4: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in Proportions |
| Estimated Value | 0.7500 | |
| Confidence Interval |
(2-Sided) 95% 0.2330 to 0.9690 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | PF-00868554 500 mg + pegIFN Alfa-2a/RBV, Placebo + pegIFN Alfa-2a/RBV |
|---|---|---|
| Comments | Week 4: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in Proportions |
| Estimated Value | 0.6250 | |
| Confidence Interval |
(2-Sided) 95% 0.0871 to 0.9191 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | PF-00868554 200 mg + pegIFN Alfa-2a/RBV, PF-00868554 500 mg + pegIFN Alfa-2a/RBV |
|---|---|---|
| Comments | Week 4: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in Proportions |
| Estimated Value | -0.0250 | |
| Confidence Interval |
(2-Sided) 95% -0.4769 to 0.4336 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | PF-00868554 300 mg + pegIFN Alfa-2a/RBV, PF-00868554 500 mg + pegIFN Alfa-2a/RBV |
|---|---|---|
| Comments | Week 4: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in Proportions |
| Estimated Value | 0.1250 | |
| Confidence Interval |
() 95% -0.4024 to 0.6049 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | PF-00868554 200 mg + pegIFN Alfa-2a/RBV, PF-00868554 300 mg + pegIFN Alfa-2a/RBV |
|---|---|---|
| Comments | Week 4: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in Proportions |
| Estimated Value | -0.1500 | |
| Confidence Interval |
(2-Sided) 95% -0.5729 to 0.3149 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | PF-00868554 200 mg + pegIFN Alfa-2a/RBV, Placebo + pegIFN Alfa-2a/RBV |
|---|---|---|
| Comments | Week 12: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in Proportions |
| Estimated Value | 0.3000 | |
| Confidence Interval |
(2-Sided) 95% -0.1836 to 0.6931 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | PF-00868554 300 mg + pegIFN Alfa-2a/RBV, Placebo + pegIFN Alfa-2a/RBV |
|---|---|---|
| Comments | Week 12: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in Proportions |
| Estimated Value | 0.3750 | |
| Confidence Interval |
(2-Sided) 95% -0.1732 to 0.7797 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | PF-00868554 500 mg + pegIFN Alfa-2a/RBV, Placebo + pegIFN Alfa-2a/RBV |
|---|---|---|
| Comments | Week 12: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in Proportions |
| Estimated Value | 0.1250 | |
| Confidence Interval |
(2-Sided) 95% -0.4024 to 0.6049 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | PF-00868554 200 mg + pegIFN Alfa-2a/RBV, PF-00868554 500 mg + pegIFN Alfa-2a/RBV |
|---|---|---|
| Comments | Week 12: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in Proportions |
| Estimated Value | 0.1750 | |
| Confidence Interval |
(2-Sided) 95% -0.2934 to 0.5917 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | PF-00868554 300 mg + pegIFN Alfa-2a/RBV, PF-00868554 500 mg + pegIFN Alfa-2a/RBV |
|---|---|---|
| Comments | Week 12: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in Proportions |
| Estimated Value | 0.2500 | |
| Confidence Interval |
(2-Sided) 95% -0.2913 to 0.6960 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | PF-00868554 200 mg + pegIFN Alfa-2a/RBV, PF-00868554 300 mg + pegIFN Alfa-2a/RBV |
|---|---|---|
| Comments | Week 12: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in Proportions |
| Estimated Value | -0.0750 | |
| Confidence Interval |
(2-Sided) 95% -0.5144 to 0.3880 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 13
| Statistical Analysis Overview | Comparison Group Selection | PF-00868554 200 mg + pegIFN Alfa-2a/RBV, Placebo + pegIFN Alfa-2a/RBV |
|---|---|---|
| Comments | Week 48: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in Proportions |
| Estimated Value | 0.1000 | |
| Confidence Interval |
(2-Sided) 95% -0.3728 to 0.5414 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 14
| Statistical Analysis Overview | Comparison Group Selection | PF-00868554 300 mg + pegIFN Alfa-2a/RBV, Placebo + pegIFN Alfa-2a/RBV |
|---|---|---|
| Comments | Week 48: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in Proportions |
| Estimated Value | 0.2500 | |
| Confidence Interval |
(2-Sided) 95% -0.2913 to 0.6960 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 15
| Statistical Analysis Overview | Comparison Group Selection | PF-00868554 500 mg + pegIFN Alfa-2a/RBV, Placebo + pegIFN Alfa-2a/RBV |
|---|---|---|
| Comments | Week 48: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in Proportions |
| Estimated Value | 0.1250 | |
| Confidence Interval |
(2-Sided) 95% -0.4024 to 0.6049 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 16
| Statistical Analysis Overview | Comparison Group Selection | PF-00868554 200 mg + pegIFN Alfa-2a/RBV, PF-00868554 500 mg + pegIFN Alfa-2a/RBV |
|---|---|---|
| Comments | Week 48: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in Proportions |
| Estimated Value | -0.0250 | |
| Confidence Interval |
() 95% -0.4769 to 0.4336 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 17
| Statistical Analysis Overview | Comparison Group Selection | PF-00868554 300 mg + pegIFN Alfa-2a/RBV, PF-00868554 500 mg + pegIFN Alfa-2a/RBV |
|---|---|---|
| Comments | Week 48: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in Proportions |
| Estimated Value | 0.1250 | |
| Confidence Interval |
(2-Sided) 95% -0.4024 to 0.6049 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 18
| Statistical Analysis Overview | Comparison Group Selection | PF-00868554 200 mg + pegIFN Alfa-2a/RBV, PF-00868554 300 mg + pegIFN Alfa-2a/RBV |
|---|---|---|
| Comments | Week 48: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in Proportions |
| Estimated Value | -0.1500 | |
| Confidence Interval |
(2-Sided) 95% -0.5729 to 0.3149 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 19
| Statistical Analysis Overview | Comparison Group Selection | PF-00868554 200 mg + pegIFN Alfa-2a/RBV, Placebo + pegIFN Alfa-2a/RBV |
|---|---|---|
| Comments | Week 60: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in Proportions |
| Estimated Value | -0.2000 | |
| Confidence Interval |
(2-Sided) 95% -0.6191 to 0.2811 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 20
| Statistical Analysis Overview | Comparison Group Selection | PF-00868554 300 mg + pegIFN Alfa-2a/RBV, Placebo + pegIFN Alfa-2a/RBV |
|---|---|---|
| Comments | Week 60: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in Proportions |
| Estimated Value | 0.0000 | |
| Confidence Interval |
(2-Sided) 95% -0.5070 to 0.5070 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 21
| Statistical Analysis Overview | Comparison Group Selection | PF-00868554 500 mg + pegIFN Alfa-2a/RBV, Placebo + pegIFN Alfa-2a/RBV |
|---|---|---|
| Comments | Week 60: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in Proportions |
| Estimated Value | 0.0000 | |
| Confidence Interval |
(2-Sided) 95% -0.5070 to 0.5070 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 22
| Statistical Analysis Overview | Comparison Group Selection | PF-00868554 200 mg + pegIFN Alfa-2a/RBV, PF-00868554 500 mg + pegIFN Alfa-2a/RBV |
|---|---|---|
| Comments | Week 60: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in Proportions |
| Estimated Value | -0.2000 | |
| Confidence Interval |
(2-Sided) 95% -0.6191 to 0.2811 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 23
| Statistical Analysis Overview | Comparison Group Selection | PF-00868554 300 mg + pegIFN Alfa-2a/RBV, PF-00868554 500 mg + pegIFN Alfa-2a/RBV |
|---|---|---|
| Comments | Week 60: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in Proportions |
| Estimated Value | 0.0000 | |
| Confidence Interval |
(2-Sided) 95% -0.5070 to 0.5070 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 24
| Statistical Analysis Overview | Comparison Group Selection | PF-00868554 200 mg + pegIFN Alfa-2a/RBV, PF-00868554 300 mg + pegIFN Alfa-2a/RBV |
|---|---|---|
| Comments | Week 60: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in Proportions |
| Estimated Value | -0.2000 | |
| Confidence Interval |
(2-Sided) 95% -0.6191 to 0.2811 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 25
| Statistical Analysis Overview | Comparison Group Selection | PF-00868554 200 mg + pegIFN Alfa-2a/RBV, Placebo + pegIFN Alfa-2a/RBV |
|---|---|---|
| Comments | Week 72: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in Proportions |
| Estimated Value | -0.2000 | |
| Confidence Interval |
(2-Sided) 95% -0.6191 to 0.2811 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 26
| Statistical Analysis Overview | Comparison Group Selection | PF-00868554 300 mg + pegIFN Alfa-2a/RBV, Placebo + pegIFN Alfa-2a/RBV |
|---|---|---|
| Comments | Week 72: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in Proportions |
| Estimated Value | 0.0000 | |
| Confidence Interval |
(2-Sided) 95% -0.5070 to 0.5070 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 27
| Statistical Analysis Overview | Comparison Group Selection | PF-00868554 500 mg + pegIFN Alfa-2a/RBV, Placebo + pegIFN Alfa-2a/RBV |
|---|---|---|
| Comments | Week 72: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in Proportions |
| Estimated Value | 0.0000 | |
| Confidence Interval |
(2-Sided) 95% -0.5070 to 0.5070 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 28
| Statistical Analysis Overview | Comparison Group Selection | PF-00868554 200 mg + pegIFN Alfa-2a/RBV, PF-00868554 500 mg + pegIFN Alfa-2a/RBV |
|---|---|---|
| Comments | Week 72: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in Proportions |
| Estimated Value | -0.2000 | |
| Confidence Interval |
(2-Sided) 95% -0.6191 to 0.2811 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 29
| Statistical Analysis Overview | Comparison Group Selection | PF-00868554 300 mg + pegIFN Alfa-2a/RBV, PF-00868554 500 mg + pegIFN Alfa-2a/RBV |
|---|---|---|
| Comments | Week 72: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in Proportions |
| Estimated Value | 0.0000 | |
| Confidence Interval |
(2-Sided) 95% -0.5070 to 0.5070 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 30
| Statistical Analysis Overview | Comparison Group Selection | PF-00868554 200 mg + pegIFN Alfa-2a/RBV, PF-00868554 300 mg + pegIFN Alfa-2a/RBV |
|---|---|---|
| Comments | Week 72: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in Proportions |
| Estimated Value | -0.2000 | |
| Confidence Interval |
(2-Sided) 95% -0.6191 to 0.2811 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Alanine Aminotransferase (ALT) Levels |
|---|---|
| Description | |
| Time Frame | Week 4, 12, 48, 72 |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS included all randomized participants who received at least 1 dose of study drug and had both baseline and at least 1 valid post-baseline endpoint measurements for HCV viral load. Here 'n' signifies participants evaluable for this measure at specified time points for each arm, respectively. |
| Arm/Group Title | PF-00868554 200 mg + pegIFN Alfa-2a/RBV | PF-00868554 300 mg + pegIFN Alfa-2a/RBV | PF-00868554 500 mg + pegIFN Alfa-2a/RBV | Placebo + pegIFN Alfa-2a/RBV |
|---|---|---|---|---|
| Arm/Group Description | PF-00868554 200 milligram (mg) (2 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegylated interferon alfa-2a (pegIFN alfa-2a) 180 microgram (mcg) subcutaneously once weekly starting from Day 1 and ribavirin (RBV) 1000 mg/day tablet orally in 2 divided doses for participants weighing less than or equal to (<=) 75 kilogram (kg); 1200 mg/day orally in 2 divided doses for participants weighing greater than (>) 75 kg. | PF-00868554 300 mg (3 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg. | PF-00868554 500 mg (5 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg. | Placebo matched to PF-00868554 tablets orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg. |
| Measure Participants | 10 | 9 | 8 | 8 |
| Week 4 (n=10, 8, 8, 8) |
31.1
(12.74)
|
28.5
(13.60)
|
51.6
(19.45)
|
47.1
(27.68)
|
| Week 12 (n=10, 7, 8, 8) |
32.9
(15.26)
|
29.4
(11.12)
|
42.5
(15.09)
|
35.6
(19.10)
|
| Week 48 (n=6, 6, 5, 4) |
35.2
(30.80)
|
25.7
(12.61)
|
24.4
(19.26)
|
148.8
(248.26)
|
| Week 72 (n=6, 5, 5, 4) |
46.0
(40.54)
|
34.0
(27.90)
|
21.8
(14.20)
|
21.5
(12.77)
|
| Title | Population Pharmacokinetics (PK) of PF-00868554 |
|---|---|
| Description | Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules. |
| Time Frame | 1, 2 and 6 hours post-dose on Day 1; 0 hour (pre-dose) on Day 7, 14, 21; 0 hour (pre-dose), 2, 6 hours post-dose on Day 28 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 4 - Modified Analysis Set |
|---|---|
| Description | Plasma HCV RNA levels were measured using the Roche COBAS Taqman assay (limit of detection: 25 IU/mL). Baseline value calculated as the average of the screening and Day 1 pre-dose measurements. |
| Time Frame | Baseline, Week 4 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Modified Analysis Set: subset of FAS that included all participants who completed the Week 4 visit. |
| Arm/Group Title | PF-00868554 200 mg + pegIFN Alfa-2a/RBV | PF-00868554 300 mg + pegIFN Alfa-2a/RBV | PF-00868554 500 mg + pegIFN Alfa-2a/RBV | Placebo + pegIFN Alfa-2a/RBV |
|---|---|---|---|---|
| Arm/Group Description | PF-00868554 200 milligram (mg) (2 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegylated interferon alfa-2a (pegIFN alfa-2a) 180 microgram (mcg) subcutaneously once weekly starting from Day 1 and ribavirin (RBV) 1000 mg/day tablet orally in 2 divided doses for participants weighing less than or equal to (<=) 75 kilogram (kg); 1200 mg/day orally in 2 divided doses for participants weighing greater than (>) 75 kg. | PF-00868554 300 mg (3 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg. | PF-00868554 500 mg (5 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg. | Placebo matched to PF-00868554 tablets orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg. |
| Measure Participants | 10 | 8 | 8 | 8 |
| Mean (Standard Deviation) [log10 IU/mL] |
-4.45887
(1.422134)
|
-4.64646
(1.982243)
|
-3.61918
(2.488935)
|
-2.10239
(1.429056)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | PF-00868554 200 mg + pegIFN Alfa-2a/RBV, Placebo + pegIFN Alfa-2a/RBV |
|---|---|---|
| Comments | An ANCOVA model was used to compare differences among treatments. Independent variables included treatment and log-transformed baseline HCV viral load. Adjusted mean difference and corresponding 95% CI were calculated. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0131 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Adjusted Mean Difference |
| Estimated Value | -2.36357 | |
| Confidence Interval |
(2-Sided) 95% -4.19228 to -0.53485 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | PF-00868554 300 mg + pegIFN Alfa-2a/RBV, Placebo + pegIFN Alfa-2a/RBV |
|---|---|---|
| Comments | An ANCOVA model was used to compare differences among treatments. Independent variables included treatment and log-transformed baseline HCV viral load. Adjusted mean difference and corresponding 95% CI were calculated. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0142 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Adjusted Mean Difference |
| Estimated Value | -2.49190 | |
| Confidence Interval |
(2-Sided) 95% -4.44619 to -0.53760 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | PF-00868554 500 mg + pegIFN Alfa-2a/RBV, Placebo + pegIFN Alfa-2a/RBV |
|---|---|---|
| Comments | An ANCOVA model was used to compare differences among treatments. Independent variables included treatment and log-transformed baseline HCV viral load. Adjusted mean difference and corresponding 95% CI were calculated. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1368 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Adjusted Mean Difference |
| Estimated Value | -1.46325 | |
| Confidence Interval |
(2-Sided) 95% -3.41898 to 0.49248 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | PF-00868554 200 mg + pegIFN Alfa-2a/RBV, PF-00868554 500 mg + pegIFN Alfa-2a/RBV |
|---|---|---|
| Comments | An ANCOVA model was used to compare differences among treatments. Independent variables included treatment and log-transformed baseline HCV viral load. Adjusted mean difference and corresponding 95% CI were calculated. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3321 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Adjusted Mean Difference |
| Estimated Value | -0.90032 | |
| Confidence Interval |
(2-Sided) 95% -2.76711 to 0.96648 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | PF-00868554 300 mg + pegIFN Alfa-2a/RBV, PF-00868554 500 mg + pegIFN Alfa-2a/RBV |
|---|---|---|
| Comments | An ANCOVA model was used to compare differences among treatments. Independent variables included treatment and log-transformed baseline HCV viral load. Adjusted mean difference and corresponding 95% CI were calculated. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2839 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Adjusted Mean Difference |
| Estimated Value | -1.02865 | |
| Confidence Interval |
(2-Sided) 95% -2.95573 to 0.89844 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | PF-00868554 200 mg + pegIFN Alfa-2a/RBV, PF-00868554 300 mg + pegIFN Alfa-2a/RBV |
|---|---|---|
| Comments | An ANCOVA model was used to compare differences among treatments. Independent variables included treatment and log-transformed baseline HCV viral load. Adjusted mean difference and corresponding 95% CI were calculated. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8891 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Adjusted Mean Difference |
| Estimated Value | 0.12833 | |
| Confidence Interval |
(2-Sided) 95% -1.73676 to 1.99342 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Adverse Events
| Time Frame | ||||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. | |||||||
| Arm/Group Title | PF-00868554 200 mg + pegIFN Alfa-2a/RBV | PF-00868554 300 mg + pegIFN Alfa-2a/RBV | PF-00868554 500 mg + pegIFN Alfa-2a/RBV | Placebo + pegIFN Alfa-2a/RBV | ||||
| Arm/Group Description | PF-00868554 200 milligram (mg) (2 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegylated interferon alfa-2a (pegIFN alfa-2a) 180 microgram (mcg) subcutaneously once weekly starting from Day 1 and ribavirin (RBV) 1000 mg/day tablet orally in 2 divided doses for participants weighing less than or equal to (<=) 75 kilogram (kg); 1200 mg/day orally in 2 divided doses for participants weighing greater than (>) 75 kg. | PF-00868554 300 mg (3 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg. | PF-00868554 500 mg (5 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg. | Placebo matched to PF-00868554 tablets orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg. | ||||
All Cause Mortality |
||||||||
| PF-00868554 200 mg + pegIFN Alfa-2a/RBV | PF-00868554 300 mg + pegIFN Alfa-2a/RBV | PF-00868554 500 mg + pegIFN Alfa-2a/RBV | Placebo + pegIFN Alfa-2a/RBV | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||
Serious Adverse Events |
||||||||
| PF-00868554 200 mg + pegIFN Alfa-2a/RBV | PF-00868554 300 mg + pegIFN Alfa-2a/RBV | PF-00868554 500 mg + pegIFN Alfa-2a/RBV | Placebo + pegIFN Alfa-2a/RBV | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/10 (0%) | 2/9 (22.2%) | 1/8 (12.5%) | 2/8 (25%) | ||||
| Endocrine disorders | ||||||||
| Thyroiditis | 0/10 (0%) | 0/9 (0%) | 0/8 (0%) | 1/8 (12.5%) | ||||
| General disorders | ||||||||
| Gait disturbance | 0/10 (0%) | 0/9 (0%) | 0/8 (0%) | 1/8 (12.5%) | ||||
| Investigations | ||||||||
| Blood creatinine increased | 0/10 (0%) | 1/9 (11.1%) | 0/8 (0%) | 0/8 (0%) | ||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||
| Metastatic gastric cancer | 0/10 (0%) | 0/9 (0%) | 0/8 (0%) | 1/8 (12.5%) | ||||
| Psychiatric disorders | ||||||||
| Confusional state | 0/10 (0%) | 0/9 (0%) | 0/8 (0%) | 1/8 (12.5%) | ||||
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Chronic obstructive pulmonary disease | 0/10 (0%) | 1/9 (11.1%) | 0/8 (0%) | 0/8 (0%) | ||||
| Pulmonary embolism | 0/10 (0%) | 0/9 (0%) | 1/8 (12.5%) | 0/8 (0%) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
| PF-00868554 200 mg + pegIFN Alfa-2a/RBV | PF-00868554 300 mg + pegIFN Alfa-2a/RBV | PF-00868554 500 mg + pegIFN Alfa-2a/RBV | Placebo + pegIFN Alfa-2a/RBV | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 10/10 (100%) | 9/9 (100%) | 8/8 (100%) | 8/8 (100%) | ||||
| Blood and lymphatic system disorders | ||||||||
| Anaemia | 5/10 (50%) | 4/9 (44.4%) | 4/8 (50%) | 3/8 (37.5%) | ||||
| Leukopenia | 2/10 (20%) | 4/9 (44.4%) | 2/8 (25%) | 3/8 (37.5%) | ||||
| Lymphopenia | 1/10 (10%) | 1/9 (11.1%) | 0/8 (0%) | 1/8 (12.5%) | ||||
| Neutropenia | 1/10 (10%) | 1/9 (11.1%) | 2/8 (25%) | 0/8 (0%) | ||||
| Thrombocytopenia | 0/10 (0%) | 0/9 (0%) | 0/8 (0%) | 2/8 (25%) | ||||
| Cardiac disorders | ||||||||
| Atrial fibrillation | 0/10 (0%) | 1/9 (11.1%) | 0/8 (0%) | 0/8 (0%) | ||||
| Congenital, familial and genetic disorders | ||||||||
| Hydrocele | 1/10 (10%) | 0/9 (0%) | 0/8 (0%) | 0/8 (0%) | ||||
| Ear and labyrinth disorders | ||||||||
| Tinnitus | 0/10 (0%) | 1/9 (11.1%) | 0/8 (0%) | 0/8 (0%) | ||||
| Endocrine disorders | ||||||||
| Hypogonadism | 1/10 (10%) | 0/9 (0%) | 0/8 (0%) | 0/8 (0%) | ||||
| Hypothyroidism | 0/10 (0%) | 0/9 (0%) | 1/8 (12.5%) | 1/8 (12.5%) | ||||
| Eye disorders | ||||||||
| Blepharitis | 0/10 (0%) | 0/9 (0%) | 1/8 (12.5%) | 0/8 (0%) | ||||
| Diabetic retinopathy | 1/10 (10%) | 0/9 (0%) | 0/8 (0%) | 0/8 (0%) | ||||
| Dry eye | 0/10 (0%) | 0/9 (0%) | 1/8 (12.5%) | 0/8 (0%) | ||||
| Eye pain | 0/10 (0%) | 0/9 (0%) | 1/8 (12.5%) | 0/8 (0%) | ||||
| Ocular hyperaemia | 0/10 (0%) | 1/9 (11.1%) | 0/8 (0%) | 0/8 (0%) | ||||
| Visual impairment | 0/10 (0%) | 0/9 (0%) | 1/8 (12.5%) | 0/8 (0%) | ||||
| Gastrointestinal disorders | ||||||||
| Abdominal distension | 0/10 (0%) | 0/9 (0%) | 1/8 (12.5%) | 0/8 (0%) | ||||
| Abdominal pain | 1/10 (10%) | 0/9 (0%) | 1/8 (12.5%) | 0/8 (0%) | ||||
| Abdominal pain upper | 1/10 (10%) | 0/9 (0%) | 0/8 (0%) | 0/8 (0%) | ||||
| Aphthous stomatitis | 1/10 (10%) | 0/9 (0%) | 0/8 (0%) | 0/8 (0%) | ||||
| Cheilitis | 0/10 (0%) | 1/9 (11.1%) | 0/8 (0%) | 0/8 (0%) | ||||
| Constipation | 0/10 (0%) | 0/9 (0%) | 0/8 (0%) | 1/8 (12.5%) | ||||
| Diarrhoea | 1/10 (10%) | 3/9 (33.3%) | 2/8 (25%) | 3/8 (37.5%) | ||||
| Dry mouth | 1/10 (10%) | 1/9 (11.1%) | 0/8 (0%) | 0/8 (0%) | ||||
| Dyspepsia | 0/10 (0%) | 2/9 (22.2%) | 0/8 (0%) | 1/8 (12.5%) | ||||
| Gastrooesophageal reflux disease | 1/10 (10%) | 0/9 (0%) | 2/8 (25%) | 2/8 (25%) | ||||
| Haemorrhoids | 0/10 (0%) | 0/9 (0%) | 0/8 (0%) | 1/8 (12.5%) | ||||
| Irritable bowel syndrome | 0/10 (0%) | 0/9 (0%) | 1/8 (12.5%) | 0/8 (0%) | ||||
| Mouth ulceration | 1/10 (10%) | 0/9 (0%) | 0/8 (0%) | 0/8 (0%) | ||||
| Nausea | 5/10 (50%) | 4/9 (44.4%) | 4/8 (50%) | 4/8 (50%) | ||||
| Toothache | 1/10 (10%) | 1/9 (11.1%) | 1/8 (12.5%) | 0/8 (0%) | ||||
| Vomiting | 0/10 (0%) | 2/9 (22.2%) | 1/8 (12.5%) | 1/8 (12.5%) | ||||
| General disorders | ||||||||
| Chest pain | 0/10 (0%) | 0/9 (0%) | 0/8 (0%) | 1/8 (12.5%) | ||||
| Chills | 1/10 (10%) | 2/9 (22.2%) | 1/8 (12.5%) | 1/8 (12.5%) | ||||
| Cyst | 0/10 (0%) | 1/9 (11.1%) | 0/8 (0%) | 0/8 (0%) | ||||
| Fatigue | 4/10 (40%) | 4/9 (44.4%) | 5/8 (62.5%) | 5/8 (62.5%) | ||||
| Influenza like illness | 0/10 (0%) | 2/9 (22.2%) | 1/8 (12.5%) | 2/8 (25%) | ||||
| Injection site erythema | 0/10 (0%) | 2/9 (22.2%) | 1/8 (12.5%) | 1/8 (12.5%) | ||||
| Injection site pruritus | 0/10 (0%) | 1/9 (11.1%) | 0/8 (0%) | 1/8 (12.5%) | ||||
| Irritability | 1/10 (10%) | 0/9 (0%) | 1/8 (12.5%) | 0/8 (0%) | ||||
| Oedema peripheral | 0/10 (0%) | 1/9 (11.1%) | 0/8 (0%) | 0/8 (0%) | ||||
| Pain | 1/10 (10%) | 1/9 (11.1%) | 1/8 (12.5%) | 2/8 (25%) | ||||
| Product taste abnormal | 0/10 (0%) | 1/9 (11.1%) | 0/8 (0%) | 0/8 (0%) | ||||
| Pyrexia | 0/10 (0%) | 1/9 (11.1%) | 1/8 (12.5%) | 0/8 (0%) | ||||
| Vestibulitis | 0/10 (0%) | 0/9 (0%) | 1/8 (12.5%) | 0/8 (0%) | ||||
| Infections and infestations | ||||||||
| Alveolar osteitis | 1/10 (10%) | 0/9 (0%) | 0/8 (0%) | 0/8 (0%) | ||||
| Bronchitis | 0/10 (0%) | 0/9 (0%) | 0/8 (0%) | 1/8 (12.5%) | ||||
| Cellulitis | 1/10 (10%) | 1/9 (11.1%) | 0/8 (0%) | 0/8 (0%) | ||||
| Fungal skin infection | 0/10 (0%) | 0/9 (0%) | 1/8 (12.5%) | 0/8 (0%) | ||||
| Gastroenteritis viral | 0/10 (0%) | 0/9 (0%) | 1/8 (12.5%) | 0/8 (0%) | ||||
| Oral candidiasis | 0/10 (0%) | 1/9 (11.1%) | 0/8 (0%) | 0/8 (0%) | ||||
| Otitis externa | 0/10 (0%) | 1/9 (11.1%) | 0/8 (0%) | 0/8 (0%) | ||||
| Pharyngitis | 1/10 (10%) | 0/9 (0%) | 0/8 (0%) | 0/8 (0%) | ||||
| Rhinitis | 0/10 (0%) | 0/9 (0%) | 1/8 (12.5%) | 0/8 (0%) | ||||
| Sinusitis | 0/10 (0%) | 1/9 (11.1%) | 0/8 (0%) | 1/8 (12.5%) | ||||
| Staphylococcal skin infection | 0/10 (0%) | 0/9 (0%) | 1/8 (12.5%) | 0/8 (0%) | ||||
| Subcutaneous abscess | 0/10 (0%) | 0/9 (0%) | 1/8 (12.5%) | 0/8 (0%) | ||||
| Tooth abscess | 0/10 (0%) | 1/9 (11.1%) | 1/8 (12.5%) | 0/8 (0%) | ||||
| Upper respiratory tract infection | 2/10 (20%) | 0/9 (0%) | 1/8 (12.5%) | 3/8 (37.5%) | ||||
| Urinary tract infection | 0/10 (0%) | 0/9 (0%) | 1/8 (12.5%) | 0/8 (0%) | ||||
| Injury, poisoning and procedural complications | ||||||||
| Excoriation | 1/10 (10%) | 0/9 (0%) | 0/8 (0%) | 0/8 (0%) | ||||
| Procedural pain | 1/10 (10%) | 0/9 (0%) | 0/8 (0%) | 0/8 (0%) | ||||
| Investigations | ||||||||
| Alanine aminotransferase increased | 0/10 (0%) | 0/9 (0%) | 0/8 (0%) | 1/8 (12.5%) | ||||
| Aspartate aminotransferase increased | 0/10 (0%) | 0/9 (0%) | 0/8 (0%) | 1/8 (12.5%) | ||||
| Weight decreased | 0/10 (0%) | 1/9 (11.1%) | 0/8 (0%) | 0/8 (0%) | ||||
| Weight increased | 1/10 (10%) | 0/9 (0%) | 0/8 (0%) | 0/8 (0%) | ||||
| Metabolism and nutrition disorders | ||||||||
| Decreased appetite | 1/10 (10%) | 1/9 (11.1%) | 1/8 (12.5%) | 2/8 (25%) | ||||
| Dehydration | 0/10 (0%) | 1/9 (11.1%) | 0/8 (0%) | 0/8 (0%) | ||||
| Hyperlipidaemia | 0/10 (0%) | 1/9 (11.1%) | 0/8 (0%) | 0/8 (0%) | ||||
| Hypoglycaemia | 0/10 (0%) | 0/9 (0%) | 0/8 (0%) | 1/8 (12.5%) | ||||
| Iron deficiency | 1/10 (10%) | 0/9 (0%) | 0/8 (0%) | 0/8 (0%) | ||||
| Musculoskeletal and connective tissue disorders | ||||||||
| Arthralgia | 1/10 (10%) | 0/9 (0%) | 1/8 (12.5%) | 2/8 (25%) | ||||
| Back pain | 1/10 (10%) | 2/9 (22.2%) | 0/8 (0%) | 2/8 (25%) | ||||
| Groin pain | 1/10 (10%) | 0/9 (0%) | 0/8 (0%) | 0/8 (0%) | ||||
| Myalgia | 2/10 (20%) | 1/9 (11.1%) | 1/8 (12.5%) | 0/8 (0%) | ||||
| Neck pain | 1/10 (10%) | 0/9 (0%) | 0/8 (0%) | 0/8 (0%) | ||||
| Pain in extremity | 1/10 (10%) | 0/9 (0%) | 0/8 (0%) | 1/8 (12.5%) | ||||
| Rheumatoid arthritis | 0/10 (0%) | 1/9 (11.1%) | 0/8 (0%) | 0/8 (0%) | ||||
| Tendonitis | 0/10 (0%) | 1/9 (11.1%) | 0/8 (0%) | 0/8 (0%) | ||||
| Nervous system disorders | ||||||||
| Areflexia | 0/10 (0%) | 0/9 (0%) | 1/8 (12.5%) | 0/8 (0%) | ||||
| Disturbance in attention | 0/10 (0%) | 2/9 (22.2%) | 0/8 (0%) | 0/8 (0%) | ||||
| Dizziness | 1/10 (10%) | 1/9 (11.1%) | 2/8 (25%) | 0/8 (0%) | ||||
| Headache | 4/10 (40%) | 6/9 (66.7%) | 4/8 (50%) | 2/8 (25%) | ||||
| Migraine with aura | 0/10 (0%) | 0/9 (0%) | 1/8 (12.5%) | 0/8 (0%) | ||||
| Paraesthesia | 0/10 (0%) | 1/9 (11.1%) | 0/8 (0%) | 0/8 (0%) | ||||
| Restless legs syndrome | 0/10 (0%) | 1/9 (11.1%) | 0/8 (0%) | 0/8 (0%) | ||||
| Sinus headache | 0/10 (0%) | 0/9 (0%) | 0/8 (0%) | 1/8 (12.5%) | ||||
| Psychiatric disorders | ||||||||
| Anxiety | 0/10 (0%) | 0/9 (0%) | 2/8 (25%) | 1/8 (12.5%) | ||||
| Depressed mood | 0/10 (0%) | 1/9 (11.1%) | 0/8 (0%) | 0/8 (0%) | ||||
| Depression | 2/10 (20%) | 1/9 (11.1%) | 2/8 (25%) | 3/8 (37.5%) | ||||
| Generalised anxiety disorder | 0/10 (0%) | 1/9 (11.1%) | 0/8 (0%) | 0/8 (0%) | ||||
| Insomnia | 6/10 (60%) | 1/9 (11.1%) | 4/8 (50%) | 2/8 (25%) | ||||
| Mood swings | 1/10 (10%) | 0/9 (0%) | 0/8 (0%) | 0/8 (0%) | ||||
| Renal and urinary disorders | ||||||||
| Pollakiuria | 0/10 (0%) | 1/9 (11.1%) | 0/8 (0%) | 0/8 (0%) | ||||
| Reproductive system and breast disorders | ||||||||
| Erectile dysfunction | 1/10 (10%) | 0/9 (0%) | 0/8 (0%) | 0/8 (0%) | ||||
| Menstrual disorder | 0/10 (0%) | 1/9 (11.1%) | 0/8 (0%) | 0/8 (0%) | ||||
| Menstruation irregular | 0/10 (0%) | 0/9 (0%) | 1/8 (12.5%) | 0/8 (0%) | ||||
| Ovarian cyst | 0/10 (0%) | 0/9 (0%) | 1/8 (12.5%) | 0/8 (0%) | ||||
| Spermatocele | 1/10 (10%) | 0/9 (0%) | 0/8 (0%) | 0/8 (0%) | ||||
| Varicocele | 1/10 (10%) | 0/9 (0%) | 0/8 (0%) | 0/8 (0%) | ||||
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Chronic obstructive pulmonary disease | 0/10 (0%) | 1/9 (11.1%) | 0/8 (0%) | 0/8 (0%) | ||||
| Cough | 3/10 (30%) | 2/9 (22.2%) | 0/8 (0%) | 2/8 (25%) | ||||
| Dyspnoea | 1/10 (10%) | 0/9 (0%) | 1/8 (12.5%) | 2/8 (25%) | ||||
| Dyspnoea exertional | 0/10 (0%) | 1/9 (11.1%) | 0/8 (0%) | 1/8 (12.5%) | ||||
| Epistaxis | 1/10 (10%) | 1/9 (11.1%) | 2/8 (25%) | 1/8 (12.5%) | ||||
| Nasal congestion | 0/10 (0%) | 0/9 (0%) | 1/8 (12.5%) | 0/8 (0%) | ||||
| Nasal dryness | 0/10 (0%) | 1/9 (11.1%) | 1/8 (12.5%) | 0/8 (0%) | ||||
| Rales | 1/10 (10%) | 0/9 (0%) | 1/8 (12.5%) | 0/8 (0%) | ||||
| Respiratory tract congestion | 0/10 (0%) | 0/9 (0%) | 1/8 (12.5%) | 0/8 (0%) | ||||
| Rhinorrhoea | 0/10 (0%) | 0/9 (0%) | 1/8 (12.5%) | 0/8 (0%) | ||||
| Rhonchi | 0/10 (0%) | 0/9 (0%) | 0/8 (0%) | 1/8 (12.5%) | ||||
| Wheezing | 1/10 (10%) | 0/9 (0%) | 0/8 (0%) | 1/8 (12.5%) | ||||
| Skin and subcutaneous tissue disorders | ||||||||
| Alopecia | 0/10 (0%) | 2/9 (22.2%) | 0/8 (0%) | 1/8 (12.5%) | ||||
| Dermatitis | 1/10 (10%) | 1/9 (11.1%) | 2/8 (25%) | 0/8 (0%) | ||||
| Dry skin | 0/10 (0%) | 1/9 (11.1%) | 2/8 (25%) | 2/8 (25%) | ||||
| Erythema | 0/10 (0%) | 0/9 (0%) | 1/8 (12.5%) | 0/8 (0%) | ||||
| Night sweats | 0/10 (0%) | 0/9 (0%) | 0/8 (0%) | 1/8 (12.5%) | ||||
| Pruritus | 1/10 (10%) | 0/9 (0%) | 1/8 (12.5%) | 3/8 (37.5%) | ||||
| Rash | 1/10 (10%) | 1/9 (11.1%) | 1/8 (12.5%) | 1/8 (12.5%) | ||||
| Rash macular | 0/10 (0%) | 0/9 (0%) | 0/8 (0%) | 1/8 (12.5%) | ||||
| Rash maculo-papular | 2/10 (20%) | 0/9 (0%) | 0/8 (0%) | 1/8 (12.5%) | ||||
| Rash papular | 0/10 (0%) | 3/9 (33.3%) | 0/8 (0%) | 0/8 (0%) | ||||
| Rash pruritic | 0/10 (0%) | 0/9 (0%) | 1/8 (12.5%) | 2/8 (25%) | ||||
| Skin lesion | 2/10 (20%) | 0/9 (0%) | 0/8 (0%) | 0/8 (0%) | ||||
| Urticaria | 0/10 (0%) | 0/9 (0%) | 1/8 (12.5%) | 0/8 (0%) | ||||
| Vascular disorders | ||||||||
| Hypertension | 0/10 (0%) | 0/9 (0%) | 1/8 (12.5%) | 0/8 (0%) | ||||
| Hypotension | 0/10 (0%) | 1/9 (11.1%) | 0/8 (0%) | 0/8 (0%) | ||||
| Phlebitis | 0/10 (0%) | 0/9 (0%) | 0/8 (0%) | 1/8 (12.5%) | ||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
| Name/Title | Pfizer ClinicalTrials.gov Call Center |
|---|---|
| Organization | Pfizer, Inc. |
| Phone | 1-800-718-1021 |
| ClinicalTrials.gov_Inquiries@pfizer.com |
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT00720434
Other Study ID Numbers:
- A8121007
First Posted:
Jul 22, 2008
Last Update Posted:
Aug 26, 2013
Last Verified:
Jun 1, 2013