A Study to Evaluate Paritaprevir With Ritonavir (ABT-450/r) When Given Together With Ombitasvir and With and Without Ribavirin (RBV) in Treatment-Naïve Participants With Genotype 1, 2 or 3 Chronic Hepatitis C Virus (HCV)
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An Open-Label, Sequential Arm, Multicenter Study to Evaluate the Antiviral Activity, Safety and Pharmacokinetics of ABT-450 With Ritonavir (ABT-450/r) Dosed in Combination With ABT-267 With and Without Ribavirin (RBV) in Treatment-Naïve Subjects With Genotype 1, 2 or 3 Chronic Hepatitis C Virus (HCV) Infection
1 other identifier
interventional
61
0 countries
N/A
Brief Summary
The purpose of this study was to evaluate the efficacy, safety and pharmacokinetics of ABT-450/r when given together with ABT-267 and with and without RBV in treatment-naïve participants with genotype 1, 2 or 3 chronic HCV infection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Sep 2011
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 23, 2011
CompletedFirst Posted
Study publicly available on registry
October 25, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedResults Posted
Study results publicly available
July 11, 2016
CompletedJuly 11, 2016
May 1, 2016
1.7 years
September 23, 2011
May 31, 2016
May 31, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Suppressed Below the Lower Limit of Quantitation (LLOQ) From Week 4 Through Week 12 [(Extended Rapid Virologic Response (eRVR)]
Analysis of the percentage of participants with hepatitis C virus ribonucleic acid less than the lower limit of quantitation (\< 25 IU/mL). Participants with missing data were imputed as failures.
Week 4 through Week 12
Secondary Outcomes (6)
Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment
Post-treatment Day 1 to Post-treatment Week 12
Percentage of Participants With Sustained Virologic Response 24 Weeks (SVR24) Post-Treatment
Post-treatment Day 1 to Post-treatment Week 24
Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) < 1000 International Units Per Milliliter (IU/mL)
Week 2
Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Below the Lower Limit of Quantitation (LLOQ) at Week 4 Rapid Virologic Response (RVR)
Week 4
Percentage of Participants With Virologic Failure During Treatment
Day 1 through Week 12
- +1 more secondary outcomes
Study Arms (6)
ABT-450/r and ABT-267 plus RBV in genotype 1 participants
EXPERIMENTALABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided twice daily (BID) in treatment-naïve participants with HCV genotype 1 infection.
ABT-450/r and ABT-267 plus RBV in genotype 2 participants
EXPERIMENTALABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve participants with HCV genotype 2 infection.
ABT-450/r and ABT-267 plus RBV in genotype 3 participants
EXPERIMENTALABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve participants with HCV genotype 3 infection.
ABT-450/r and ABT-267 in genotype 1 participants
EXPERIMENTALABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve participants with HCV genotype 1 infection.
ABT-450/r and ABT-267 in genotype 2 participants
EXPERIMENTALABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve participants with HCV genotype 2 infection.
ABT-450/r and ABT-267 in genotype 3 participants
EXPERIMENTALABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve participants with HCV genotype 3 infection.
Interventions
tablets
tablets
tablets
capsules
Eligibility Criteria
You may qualify if:
- Participants who had a body mass index 18 to \< 35 kg/m\^2.
- Females were either postmenopausal for at least 2 years, surgically sterile, or willing to use at least 2 effective forms of birth control.
- Males must have been surgically sterile or agreed to use at least 2 effective forms of birth control throughout the course of the study.
- Participants were in a condition of general good health, other than the HCV infection.
- Participants had a chronic HCV genotype 1, 2, or 3 infection for at least 6 months, a plasma HCV RNA \> 50,000 IU/mL, and FibroTest score \<= 0.72 and aspartate aminotransferase (AST) to platelet ratio index \<= 2, Fibroscan® result of \< 9.6 kilopascal (kPa), or absence of cirrhosis based on a liver biopsy.
You may not qualify if:
- Positive drug screen
- Previous use of anti-HCV agents
- History of cardiac disease
- History of uncontrolled diabetes or diabetes requiring insulin
- Abnormal laboratory results
- Females who were pregnant or planned to become pregnant within 6 months after their last dose of study drug/RBV or were breastfeeding; males whose partners were pregnant or would become pregnant within 6 months after their last dose of study drug/RBV
- Positive test result for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus (HIV) antibody (Ab). Negative HIV status was to be confirmed at screening.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Medical Services
- Organization
- AbbVie
Study Officials
- STUDY DIRECTOR
Andrew Campbell, MD
AbbVie
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 23, 2011
First Posted
October 25, 2011
Study Start
September 1, 2011
Primary Completion
May 1, 2013
Study Completion
May 1, 2013
Last Updated
July 11, 2016
Results First Posted
July 11, 2016
Record last verified: 2016-05