PEARL-II: A Study to Evaluate the Safety and Effect of the Experimental Drugs ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 in Subjects With Chronic Hepatitis C
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 1b (HCV GT1b) infection without cirrhosis.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
Detailed Description
A randomized, open-label, 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-experienced, noncirrhotic participants with chronic hepatitis C virus genotype 1b (HCV GT1b) 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
Tablet
|
Experimental: ABT-450/r/ABT-267 and ABT-333 ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg 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:
|
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 with and without RBV) compared with the historical control rate for noncirrhotic, treatment-experienced participants with HCV GT1b 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 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 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 with and without RBV) compared with the historical control rate for noncirrhotic, treatment-experienced participants with HCV GT1b 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 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 was calculated using the Wilson score method for the single proportion because the point estimate was 0%.
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 1b-infection (HCV RNA level greater than or equal to 10,000 IU/mL at screening)
-
Subject's hepatitis C virus genotype is subgenotype 1b at Screening without co infection with any other genotype/subgenotype.
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
-
Use of contraindicated medications within 2 weeks of dosing
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- AbbVie (prior sponsor, Abbott)
Investigators
- Study Director: Jeffrey Enejosa, MD, AbbVie
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- M13-389
- 2011-005740-95
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 |
---|---|---|
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 |
Period Title: Overall Study | ||
STARTED | 92 | 95 |
COMPLETED | 89 | 94 |
NOT COMPLETED | 3 | 1 |
Baseline Characteristics
Arm/Group Title | ABT-450/r/ABT-267 and ABT-333, Plus RBV | ABT-450/r/ABT-267 and ABT-333 | 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 | Total of all reporting groups |
Overall Participants | 91 | 95 | 186 |
Age (years) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [years] |
54.2
(10.90)
|
54.2
(10.51)
|
54.2
(10.67)
|
Sex: Female, Male (Count of Participants) | |||
Female |
46
50.5%
|
38
40%
|
84
45.2%
|
Male |
45
49.5%
|
57
60%
|
102
54.8%
|
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 with and without RBV) compared with the historical control rate for noncirrhotic, treatment-experienced participants with HCV GT1b 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 with HCV subgenotype 1B (GT1b) infection who received at least 1 dose of coformulated ABT-450/r/ABT-267 and ABT-333, with or without RBV (intent-to-treat [ITT GT1b] 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 |
---|---|---|
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 |
Measure Participants | 88 | 91 |
Number [percentage of participants] |
97.7
107.4%
|
100
105.3%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | ABT-450/r/ABT-267 and ABT-333 |
---|---|---|
Comments | Planned enrollment is 210 to allow ≥200 GT1b-infected participants to be treated with combination formulation of ABT-450/r/ABT-267 and ABT-333 with and without RBV. Enrollment terminated after 187 participants were randomized. Assuming a rate of 82% in each arm, a sample size of 90 participants per arm will have >90% power to demonstrate noninferiority of each arm to the historical rate 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 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 for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 64% to achieve noninferiority. | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Percentage of Participants |
Estimated Value | 100 | |
Confidence Interval |
(2-Sided) 95% 95.9 to 100.0 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | 95% CI was calculated using the Wilson score method for the single proportion because the point estimate was 100%. |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | ABT-450/r/ABT-267 and ABT-333, Plus RBV |
---|---|---|
Comments | Assuming a rate of 82% in each arm, a sample size of 90 participants per arm will have >90% power to demonstrate noninferiority of each arm to the historical rate 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 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 for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 64% to achieve noninferiority. | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Percentage of Participants |
Estimated Value | 97.7 | |
Confidence Interval |
(2-Sided) 95% 94.6 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 with HCV subgenotype 1B (GT1b) infection who received at least 1 dose of coformulated ABT-450/r/ABT-267 and ABT-333, with or without RBV (intent-to-treat [ITT GT1b]) 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 |
---|---|---|
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 |
Measure Participants | 88 | 91 |
Number [percentage of participants] |
42.0
46.2%
|
5.5
5.8%
|
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 |
---|---|---|
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 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 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 with and without RBV) compared with the historical control rate for noncirrhotic, treatment-experienced participants with HCV GT1b 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 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 with HCV subgenotype 1B (GT1b) infection who received at least 1 dose of coformulated ABT-450/r/ABT-267 and ABT-333, with or without RBV (intent-to-treat [ITT GT1b] 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 |
---|---|---|
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 |
Measure Participants | 88 | 91 |
Number [percentage of participants] |
97.7
107.4%
|
100
105.3%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | ABT-450/r/ABT-267 and ABT-333, Plus RBV |
---|---|---|
Comments | ||
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 | 97.7 | |
Confidence Interval |
(2-Sided) 95% 94.6 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 |
---|---|---|
Comments | ||
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 | 100 | |
Confidence Interval |
(2-Sided) 95% 95.9 to 100 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | 95% CI was calculated using the Wilson score method for the single proportion; 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 |
---|---|---|
Comments | ||
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 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% confidence interval for the difference in percentage of participants with sustained virologic response at 12 weeks after treatment must exceed -10.5% to achieve noninferiority. | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Percentage of Participants |
Estimated Value | 2.3 | |
Confidence Interval |
(2-Sided) 95% -0.8 to 5.4 |
|
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 with HCV subgenotype 1B (GT1b) infection who received at least 1 dose of coformulated ABT-450/r/ABT-267 and ABT-333, with or without RBV (intent-to-treat [ITT GT1b] population). |
Arm/Group Title | ABT-450/r/ABT-267 and ABT-333, Plus RBV | ABT-450/r/ABT-267 and ABT-333 |
---|---|---|
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 |
Measure Participants | 88 | 91 |
Rebound |
0
0%
|
0
0%
|
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 was calculated using the Wilson score method for the single proportion because the point estimate was 0%. |
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 with HCV subgenotype 1B (GT1b) infection who received at least 1 dose of coformulated ABT-450/r/ABT-267 and ABT-333, with or without RBV (ITT GT1b 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 |
---|---|---|
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 |
Measure Participants | 86 | 91 |
Number (95% Confidence Interval) [percentage of participants] |
0
0%
|
0
0%
|
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 participation in the study (up to 64 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 | ||
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 | ||
All Cause Mortality |
||||
ABT-450/r/ABT-267 and ABT-333, Plus RBV | ABT-450/r/ABT-267 and ABT-333 | |||
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 | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 2/91 (2.2%) | 2/95 (2.1%) | ||
Gastrointestinal disorders | ||||
PANCREATITIS | 1/91 (1.1%) | 0/95 (0%) | ||
Infections and infestations | ||||
CELLULITIS | 0/91 (0%) | 1/95 (1.1%) | ||
Musculoskeletal and connective tissue disorders | ||||
OSTEOARTHRITIS | 1/91 (1.1%) | 0/95 (0%) | ||
Renal and urinary disorders | ||||
NEPHROLITHIASIS | 0/91 (0%) | 1/95 (1.1%) | ||
Other (Not Including Serious) Adverse Events |
||||
ABT-450/r/ABT-267 and ABT-333, Plus RBV | ABT-450/r/ABT-267 and ABT-333 | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 71/91 (78%) | 62/95 (65.3%) | ||
Blood and lymphatic system disorders | ||||
ANAEMIA | 10/91 (11%) | 0/95 (0%) | ||
Cardiac disorders | ||||
PALPITATIONS | 5/91 (5.5%) | 2/95 (2.1%) | ||
Gastrointestinal disorders | ||||
CONSTIPATION | 5/91 (5.5%) | 1/95 (1.1%) | ||
DIARRHOEA | 12/91 (13.2%) | 12/95 (12.6%) | ||
NAUSEA | 19/91 (20.9%) | 6/95 (6.3%) | ||
General disorders | ||||
ASTHENIA | 11/91 (12.1%) | 7/95 (7.4%) | ||
FATIGUE | 29/91 (31.9%) | 16/95 (16.8%) | ||
IRRITABILITY | 5/91 (5.5%) | 1/95 (1.1%) | ||
PYREXIA | 6/91 (6.6%) | 8/95 (8.4%) | ||
Hepatobiliary disorders | ||||
HYPERBILIRUBINAEMIA | 5/91 (5.5%) | 2/95 (2.1%) | ||
Infections and infestations | ||||
INFLUENZA | 2/91 (2.2%) | 6/95 (6.3%) | ||
NASOPHARYNGITIS | 6/91 (6.6%) | 6/95 (6.3%) | ||
Investigations | ||||
BLOOD BILIRUBIN INCREASED | 8/91 (8.8%) | 0/95 (0%) | ||
Metabolism and nutrition disorders | ||||
DECREASED APPETITE | 9/91 (9.9%) | 2/95 (2.1%) | ||
Musculoskeletal and connective tissue disorders | ||||
ARTHRALGIA | 6/91 (6.6%) | 6/95 (6.3%) | ||
MYALGIA | 6/91 (6.6%) | 4/95 (4.2%) | ||
Nervous system disorders | ||||
DIZZINESS | 8/91 (8.8%) | 3/95 (3.2%) | ||
HEADACHE | 22/91 (24.2%) | 22/95 (23.2%) | ||
Psychiatric disorders | ||||
INSOMNIA | 13/91 (14.3%) | 3/95 (3.2%) | ||
Respiratory, thoracic and mediastinal disorders | ||||
COUGH | 3/91 (3.3%) | 7/95 (7.4%) | ||
DYSPNOEA | 8/91 (8.8%) | 2/95 (2.1%) | ||
DYSPNOEA EXERTIONAL | 5/91 (5.5%) | 1/95 (1.1%) | ||
Skin and subcutaneous tissue disorders | ||||
PRURITUS | 13/91 (14.3%) | 8/95 (8.4%) | ||
RASH | 8/91 (8.8%) | 1/95 (1.1%) | ||
Vascular disorders | ||||
HYPERTENSION | 5/91 (5.5%) | 4/95 (4.2%) |
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 |
- M13-389
- 2011-005740-95