PEARL-IV: A Study to Evaluate Chronic Hepatitis C Infection in Adults With Genotype 1a Infection
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the safety and antiviral activity of ABT-450/ritonavir/ABT- 267 (ABT-450/r/ABT-267; ABT-450 also known as paritaprevir; ABT-267 also known as ombitasvir) and ABT-333 (also known as dasabuvir) with and without ribavirin (RBV) in patients with chronic hepatitis C virus genotype 1a (HCV GT1a) infection without cirrhosis.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
Detailed Description
A randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety and antiviral activity of the combination of ABT-450/ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 with and without ribavirin (RBV) in treatment-naive, noncirrhotic participants with chronic hepatitis C virus genotype 1a (HCV GT1a) infection.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: ABT-450/r/ABT-267 and ABT-333, Plus RBV ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks |
Drug: ABT-450/r/ABT-267, ABT-333
Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet
Other Names:
Drug: Ribavirin
Capsule
|
Experimental: ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks |
Drug: ABT-450/r/ABT-267, ABT-333
Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet
Other Names:
Drug: Placebo for Ribavirin
Capsule
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Primary Analyses [12 weeks after last dose of study drug]
The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug. The LLOQ for the assay was 25 IU/mL. The primary efficacy endpoints were noninferiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment in each treatment arm (ABT-450/r/ABT-267 and ABT-333, plus either placebo RBV or RBV) compared with the historical control rate for noncirrhotic, treatment-naïve participants with HCV GT1a infection treated with telaprevir and peginterferon(pegIFN)/RBV.
Secondary Outcome Measures
- Percentage of Participants With Hemoglobin Decrease to Below the Lower Limit of Normal (LLN) At End of Treatment [Baseline (Day 1) and Week 12 (End of Treatment)]
The percentage of participants with a decrease in hemoglobin from greater than or equal to the lower limit of normal (≥ LLN) at baseline to < LLN at the end of treatment.
- Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Secondary Analyses [12 weeks after last dose of study drug]
The percentage of participants with sustained virologic response (plasma HCV RNA less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug. The secondary efficacy endpoints were superiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment in each treatment arm (ABT-450/r/ABT-267 and ABT-333, plus either placebo RBV or RBV) compared with the historical control rate for noncirrhotic, treatment-naïve participants with HCV GT1a infection treated with telaprevir and pegIFN/RBV; and the noninferiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment who received ABT-450/r/ABT-267 and ABT-333, plus placebo RBV compared with those who received ABT-450/r/ABT-267 and ABT-333, plus RBV.
- Percentage of Participants With Virologic Failure During Treatment [Baseline (Day 1), and Treatment Weeks 1, 2, 4, 6, 8, 10, and 12]
Virologic failure during treatment was defined as rebound (confirmed HCV RNA greater than or equal to the lower limit of quantitation [≥ LLOQ] after HCV RNA < LLOQ during treatment, or confirmed increase from the lowest value post baseline in HCV RNA [2 consecutive HCV RNA measurements > 1 log10 IU/mL above the lowest value post baseline] at any time point during treatment), or failure to suppress (HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks [≥ 36 days] of treatment).
- Percentage of Participants With Virologic Relapse After Treatment [Between End of Treatment (Week 12) and Post-treatment (up to Week 12 Post-Treatment)]
Participants who completed treatment with plasma HCV RNA less than the lower limit of quantification (<LLOQ) at the end of treatment were considered to have virologic relapse if they had confirmed HCV RNA ≥ LLOQ during the post-treatment period. 95% CI calculated using the normal approximation to the binomial distribution.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Females must be practicing specific forms of birth control on study treatment, or be post-menopausal for more than 2 years or surgically sterile
-
Chronic hepatitis C, genotype 1a-infection (HCV RNA level greater than or equal to 10,000 IU/mL at screening)
-
Subject has never received antiviral treatment for hepatitis C infection
-
No evidence of liver cirrhosis
Exclusion Criteria:
-
Significant liver disease with any cause other than HCV as the primary cause
-
Positive hepatitis B surface antigen or anti-human immunodeficiency virus antibody
-
Positive screen for drugs or alcohol
-
Significant sensitivity to any drug
-
Use of contraindicated medications within 2 weeks of dosing
-
Abnormal laboratory tests
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- AbbVie
Investigators
- Study Director: Yan Luo, MD, AbbVie
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- M14-002
- 2012-005522-29
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | ABT-450/r/ABT-267 and ABT-333, Plus RBV | ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV |
---|---|---|
Arm/Group Description | ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks | ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks |
Period Title: Overall Study | ||
STARTED | 100 | 205 |
COMPLETED | 94 | 184 |
NOT COMPLETED | 6 | 21 |
Baseline Characteristics
Arm/Group Title | ABT-450/r/ABT-267 and ABT-333, Plus RBV | ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV | Total |
---|---|---|---|
Arm/Group Description | ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks | ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks | Total of all reporting groups |
Overall Participants | 100 | 205 | 305 |
Age (years) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [years] |
51.6
(10.99)
|
51.4
(10.64)
|
51.5
(10.74)
|
Sex: Female, Male (Count of Participants) | |||
Female |
30
30%
|
76
37.1%
|
106
34.8%
|
Male |
70
70%
|
129
62.9%
|
199
65.2%
|
Outcome Measures
Title | Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Primary Analyses |
---|---|
Description | The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug. The LLOQ for the assay was 25 IU/mL. The primary efficacy endpoints were noninferiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment in each treatment arm (ABT-450/r/ABT-267 and ABT-333, plus either placebo RBV or RBV) compared with the historical control rate for noncirrhotic, treatment-naïve participants with HCV GT1a infection treated with telaprevir and peginterferon(pegIFN)/RBV. |
Time Frame | 12 weeks after last dose of study drug |
Outcome Measure Data
Analysis Population Description |
---|
All randomized participants who received at least 1 dose of study drug (intent-to-treat [ITT] population); participants with missing data were counted as non-responders. |
Arm/Group Title | ABT-450/r/ABT-267 and ABT-333, Plus RBV | ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV |
---|---|---|
Arm/Group Description | ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks | ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks |
Measure Participants | 100 | 205 |
Number [percentage of participants] |
97.0
97%
|
90.2
44%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV |
---|---|---|
Comments | Based on a 2-sided significance level of 0.05 and an underlying rate of ≥90% in the ABT-450/r/ABT-267 and ABT-333, plus RBV arm (100 participants) and ≥85% in the ABT-450/r/ABT-267 and ABT-333, plus Placebo RBV arm (200 participants) provides >95% power to demonstrate noninferiority of each regimen to the historical rate for telaprevir plus pegIFN and RBV therapy (75%) (based on the normal approximation of a single binomial proportion in a one-sample test for superiority). | |
Type of Statistical Test | Non-Inferiority or Equivalence (legacy) | |
Comments | The noninferiority of the rate of sustained virologic response at 12 weeks after treatment for the ABT-450/r/ABT-267 and ABT-333, plus placebo RBV treatment group as compared with the historical rate for telaprevir plus pegIFN-RBV was analyzed; the lower confidence bound of the 2-sided 95% confidence interval (95% CI) for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 65% to achieve noninferiority. | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Percentage of Participants |
Estimated Value | 90.2 | |
Confidence Interval |
(2-Sided) 95% 86.2 to 94.3 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | 95% CI was calculated using the normal approximation to the binomial distribution. |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | ABT-450/r/ABT-267 and ABT-333, Plus RBV |
---|---|---|
Comments | Based on a 2-sided significance level of 0.05 and an underlying rate of ≥90% in the ABT-450/r/ABT-267 and ABT-333, plus RBV arm (100 participants) and ≥85% in the ABT-450/r/ABT-267 and ABT-333, plus Placebo RBV arm (200 participants) provides >95% power to demonstrate noninferiority of each regimen to the historical rate for telaprevir plus pegIFN and RBV therapy (75%) (based on the normal approximation of a single binomial proportion in a one-sample test for superiority). | |
Type of Statistical Test | Non-Inferiority or Equivalence (legacy) | |
Comments | The noninferiority of the rate of sustained virologic response at 12 weeks for the ABT-450/r/ABT-267 and ABT-333, plus RBV treatment group as compared with the historical rate for telaprevir plus pegIFN-RBV was analyzed; the lower confidence bound of the 2-sided 95% CI for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 65% to achieve noninferiority. | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Percentage of Participants |
Estimated Value | 97.0 | |
Confidence Interval |
(2-Sided) 95% 93.7 to 100.0 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | 95% CI was calculated using the normal approximation to the binomial distribution. |
Title | Percentage of Participants With Hemoglobin Decrease to Below the Lower Limit of Normal (LLN) At End of Treatment |
---|---|
Description | The percentage of participants with a decrease in hemoglobin from greater than or equal to the lower limit of normal (≥ LLN) at baseline to < LLN at the end of treatment. |
Time Frame | Baseline (Day 1) and Week 12 (End of Treatment) |
Outcome Measure Data
Analysis Population Description |
---|
All randomized participants who received at least 1 dose of study drug (ITT population) and had hemoglobin ≥ LLN reference range at baseline. |
Arm/Group Title | ABT-450/r/ABT-267 and ABT-333, Plus RBV | ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV |
---|---|---|
Arm/Group Description | ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks | ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks |
Measure Participants | 100 | 203 |
Number [percentage of participants] |
42.0
42%
|
3.9
1.9%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | ABT-450/r/ABT-267 and ABT-333, Plus RBV, ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.001 |
Comments | ||
Method | Fisher Exact | |
Comments |
Title | Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Secondary Analyses |
---|---|
Description | The percentage of participants with sustained virologic response (plasma HCV RNA less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug. The secondary efficacy endpoints were superiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment in each treatment arm (ABT-450/r/ABT-267 and ABT-333, plus either placebo RBV or RBV) compared with the historical control rate for noncirrhotic, treatment-naïve participants with HCV GT1a infection treated with telaprevir and pegIFN/RBV; and the noninferiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment who received ABT-450/r/ABT-267 and ABT-333, plus placebo RBV compared with those who received ABT-450/r/ABT-267 and ABT-333, plus RBV. |
Time Frame | 12 weeks after last dose of study drug |
Outcome Measure Data
Analysis Population Description |
---|
All randomized participants who received at least 1 dose of study drug (ITT population); participants with missing data were counted as non-responders. |
Arm/Group Title | ABT-450/r/ABT-267 and ABT-333, Plus RBV | ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV |
---|---|---|
Arm/Group Description | ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks | ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks |
Measure Participants | 100 | 205 |
Number [percentage of participants] |
97.0
97%
|
90.2
44%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | ABT-450/r/ABT-267 and ABT-333, Plus RBV |
---|---|---|
Comments | Based on a 2-sided significance level of 0.05 and an underlying rate of ≥90% in the ABT-450/r/ABT-267 and ABT-333, plus RBV arm (100 participants) and ≥85% in the ABT-450/r/ABT-267 and ABT-333, plus Placebo RBV arm (200 participants) provides >90% power to demonstrate superiority of each regimen to the historical rate for telaprevir plus pegIFN and RBV therapy (75%) (based on the normal approximation of a single binomial proportion in a one-sample test for superiority). | |
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Percentage of Participants |
Estimated Value | 97.0 | |
Confidence Interval |
(2-Sided) 95% 93.7 to 100.0 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | 95% CI was calculated using the normal approximation to the binomial distribution; the lower confidence bound for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 75% to achieve superiority. |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV |
---|---|---|
Comments | Based on a 2-sided significance level of 0.05 and an underlying rate of ≥90% in the ABT-450/r/ABT-267 and ABT-333, plus RBV arm (100 participants) and ≥85% in the ABT-450/r/ABT-267 and ABT-333, plus Placebo RBV arm (200 participants) provides >90% power to demonstrate superiority of each regimen to the historical rate for telaprevir plus pegIFN and RBV therapy (75%) (based on the normal approximation of a single binomial proportion in a one-sample test for superiority). | |
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Percentage of Participants |
Estimated Value | 90.2 | |
Confidence Interval |
(2-Sided) 95% 86.2 to 94.3 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | 95% CI was calculated using the normal approximation to the binomial distribution; the lower confidence bound for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 75% to achieve superiority. |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | ABT-450/r/ABT-267 and ABT-333, Plus RBV, ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV |
---|---|---|
Comments | Based on a 2-sided significance level of 0.05 and an underlying rate of ≥90% in the ABT-450/r/ABT-267 and ABT-333, plus RBV arm (100 participants) and ≥85% in the ABT-450/r/ABT-267 and ABT-333, plus Placebo RBV arm (200 participants) provides >95% power to demonstrate noninferiority of the ABT-450/r/ABT-267 and ABT-333, plus RBV arm compared with the ABT-450/r/ABT-267 and ABT-333, plus Placebo RBV arm (normal approximation of a single binomial proportion in a one-sample test for superiority). | |
Type of Statistical Test | Non-Inferiority or Equivalence (legacy) | |
Comments | Noninferiority of the rate of sustained virologic response at 12 weeks after treatment in the ABT-450/r/ABT-267 and ABT-333, plus placebo RBV treatment group as compared with the ABT-450/r/ABT-267 and ABT-333, plus RBV treatment group was analyzed using a noninferiority margin of -10.5%; the lower confidence bound of the 2-sided 95% CI (calculated using normal approximation to the binomial distribution)for the difference in percentage of participants must exceed -10.5% to achieve noninferiority. | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in Percentage of Participants |
Estimated Value | -6.8 | |
Confidence Interval |
(2-Sided) 95% -12.0 to -1.5 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | 95% CI was calculated using the normal approximation to the binomial distribution. |
Title | Percentage of Participants With Virologic Failure During Treatment |
---|---|
Description | Virologic failure during treatment was defined as rebound (confirmed HCV RNA greater than or equal to the lower limit of quantitation [≥ LLOQ] after HCV RNA < LLOQ during treatment, or confirmed increase from the lowest value post baseline in HCV RNA [2 consecutive HCV RNA measurements > 1 log10 IU/mL above the lowest value post baseline] at any time point during treatment), or failure to suppress (HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks [≥ 36 days] of treatment). |
Time Frame | Baseline (Day 1), and Treatment Weeks 1, 2, 4, 6, 8, 10, and 12 |
Outcome Measure Data
Analysis Population Description |
---|
All randomized participants who received at least 1 dose of study drug (ITT population). |
Arm/Group Title | ABT-450/r/ABT-267 and ABT-333, Plus RBV | ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV |
---|---|---|
Arm/Group Description | ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks | ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks |
Measure Participants | 100 | 205 |
Rebound |
1.0
1%
|
2.9
1.4%
|
Failure to suppress |
0
0%
|
0
0%
|
Title | Percentage of Participants With Virologic Relapse After Treatment |
---|---|
Description | Participants who completed treatment with plasma HCV RNA less than the lower limit of quantification (<LLOQ) at the end of treatment were considered to have virologic relapse if they had confirmed HCV RNA ≥ LLOQ during the post-treatment period. 95% CI calculated using the normal approximation to the binomial distribution. |
Time Frame | Between End of Treatment (Week 12) and Post-treatment (up to Week 12 Post-Treatment) |
Outcome Measure Data
Analysis Population Description |
---|
All randomized participants who received at least 1 dose of study drug (ITT population) with HCV RNA < LLOQ at the final treatment visit and completed treatment. |
Arm/Group Title | ABT-450/r/ABT-267 and ABT-333, Plus RBV | ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV |
---|---|---|
Arm/Group Description | ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks | ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks |
Measure Participants | 98 | 194 |
Number (95% Confidence Interval) [percentage of participants] |
1.0
1%
|
5.2
2.5%
|
Adverse Events
Time Frame | AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of the study (up to 65 weeks). | |||
---|---|---|---|---|
Adverse Event Reporting Description | ||||
Arm/Group Title | ABT-450/r/ABT-267 and ABT-333, Plus RBV | ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV | ||
Arm/Group Description | ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks | ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks | ||
All Cause Mortality |
||||
ABT-450/r/ABT-267 and ABT-333, Plus RBV | ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
ABT-450/r/ABT-267 and ABT-333, Plus RBV | ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 3/100 (3%) | 1/205 (0.5%) | ||
Blood and lymphatic system disorders | ||||
ANAEMIA | 1/100 (1%) | 0/205 (0%) | ||
Gastrointestinal disorders | ||||
PANCREATITIS | 1/100 (1%) | 0/205 (0%) | ||
SMALL INTESTINAL OBSTRUCTION | 1/100 (1%) | 0/205 (0%) | ||
Infections and infestations | ||||
DIVERTICULITIS | 0/100 (0%) | 1/205 (0.5%) | ||
Other (Not Including Serious) Adverse Events |
||||
ABT-450/r/ABT-267 and ABT-333, Plus RBV | ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 81/100 (81%) | 138/205 (67.3%) | ||
Blood and lymphatic system disorders | ||||
ANAEMIA | 5/100 (5%) | 0/205 (0%) | ||
Gastrointestinal disorders | ||||
DIARRHOEA | 14/100 (14%) | 33/205 (16.1%) | ||
DYSPEPSIA | 5/100 (5%) | 5/205 (2.4%) | ||
NAUSEA | 21/100 (21%) | 28/205 (13.7%) | ||
General disorders | ||||
FATIGUE | 46/100 (46%) | 72/205 (35.1%) | ||
IRRITABILITY | 8/100 (8%) | 14/205 (6.8%) | ||
Infections and infestations | ||||
UPPER RESPIRATORY TRACT INFECTION | 6/100 (6%) | 8/205 (3.9%) | ||
Investigations | ||||
BLOOD BILIRUBIN INCREASED | 7/100 (7%) | 0/205 (0%) | ||
Musculoskeletal and connective tissue disorders | ||||
ARTHRALGIA | 9/100 (9%) | 5/205 (2.4%) | ||
BACK PAIN | 5/100 (5%) | 12/205 (5.9%) | ||
Nervous system disorders | ||||
DIZZINESS | 8/100 (8%) | 13/205 (6.3%) | ||
HEADACHE | 25/100 (25%) | 58/205 (28.3%) | ||
MEMORY IMPAIRMENT | 1/100 (1%) | 14/205 (6.8%) | ||
Psychiatric disorders | ||||
INSOMNIA | 17/100 (17%) | 16/205 (7.8%) | ||
Respiratory, thoracic and mediastinal disorders | ||||
COUGH | 5/100 (5%) | 12/205 (5.9%) | ||
DYSPNOEA EXERTIONAL | 7/100 (7%) | 1/205 (0.5%) | ||
Skin and subcutaneous tissue disorders | ||||
DRY SKIN | 6/100 (6%) | 2/205 (1%) | ||
PRURITUS | 10/100 (10%) | 12/205 (5.9%) | ||
RASH | 5/100 (5%) | 11/205 (5.4%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
Results Point of Contact
Name/Title | Global Medical Information |
---|---|
Organization | AbbVie |
Phone | 800-633-9110 |
- M14-002
- 2012-005522-29