Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT- 267 (ABT-450/r/ABT-267) in Japanese Adults With Genotype 2 Chronic Hepatitis C Virus (HCV) Infection
- Registration Number
- NCT02023112
- Lead Sponsor
- AbbVie
- Brief Summary
This is a Phase 3, randomized, open-label, multicenter study, enrolling non-cirrhotic and cirrhotic subjects. The purpose of this study is to evaluate the efficacy and safety of ABT-450/r/ABT-267 co-administered with weight-based RBV for 12 or 16 weeks in adult chronic HCV genotype 2-infected treatment-naïve and interferon (IFN) treatment-experienced subjects with and without compensated cirrhosis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 171
- Chronic HCV-infection prior to study enrollment
- Screening laboratory result indicating HCV genotype 2 infection
- Subject has plasma HCV ribonucleic acid (RNA) level greater than 10,000 IU/mL at Screening
- Voluntarily sign an informed consent
- Co-infection of Hepatitis B Virus (HBV), human immunodeficiency virus (HIV) and any HCV genotype other than genotype 2
- Prior therapy with direct acting antiviral agents for the treatment of HCV, including telaprevir, simeprevir and boceprevir
- Any cause of liver disease other than chronic HCV-infection, including but not limited to the following: hemochromatosis; alpha-1 antitrypsin deficiency; Wilson's disease; autoimmune hepatitis; alcoholic liver disease; drug-related liver disease
- Clinically significant laboratory abnormalities
- Uncontrolled clinically significant disease, disorder or medical illness
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ABT-450/r/ABT-267 plus RBV for 12 weeks ABT-450/r/ABT-267 ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based ribavirin (RBV; 400 to 1,000 mg/day, divided twice daily) for 12 weeks ABT-450/r/ABT-267 plus RBV for 12 weeks Ribavirin ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based ribavirin (RBV; 400 to 1,000 mg/day, divided twice daily) for 12 weeks ABT-450/r/ABT-267 plus RBV for 16 weeks Ribavirin ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 16 weeks ABT-450/r/ABT-267 plus RBV for 16 weeks ABT-450/r/ABT-267 ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 16 weeks
- Primary Outcome Measures
Name Time Method Percentage of Non-cirrhotic, Treatment-naive Participants in Each Treatment Group With a Sustained Virologic Response 12 Weeks Post-treatment (SVR12) 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.
- Secondary Outcome Measures
Name Time Method Percentage of Participants in Each Treatment Arm With On-treatment Virologic Failure During the Treatment Period for Each Treatment Arm Within Different Subpopulations 12 or 16 weeks (end of treatment period) The percentage of participants with on-treatment virologic failure in each treatment arm within the following subpopulations: noncirrhotic participants; noncirrhotic treatment-experienced (T-exp) participants; participants with compensated cirrhosis.
On-treatment virologic failure was defined as rebound (confirmed HCV RNA ≥ LLOQ after HCV RNA \< LLOQ during treatment, or confirmed increase from nadir in HCV RNA \[\> 1 log10 IU/mL above nadir\] at any time point during treatment) or failure to suppress HCV during treatment (all on-treatment values of HCV RNA ≥ LLOQ with at least 6 weeks of treatment).Percentage of Participants With Post-treatment Relapse Within Different Subpopulations within 12 weeks after the last dose of study drug The percentage of participants with relapse by post-treatment Week 12 in each treatment arm within the following subpopulations: noncirrhotic participants; noncirrhotic treatment-experienced (T-exp) participants; participants with compensated cirrhosis.
Relapse by post-treatment Week 12 was defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of study drug for a participant with HCV RNA \< LLOQ at the final treatment visit and who completed study treatment. Completion of treatment was defined as a study drug duration ≥ 77 days for the 12-week treatment arm or ≥ 105 days for the 16-week treatment arm.Percentage of Participants in Each Treatment Arm With On-treatment Virologic Failure During the Treatment Period 12 or 16 weeks (end of treatment period) On-treatment virologic failure was defined as rebound (confirmed HCV RNA ≥ LLOQ after HCV RNA \< LLOQ during treatment, or confirmed increase from nadir in HCV RNA \[\> 1 log10 IU/mL above nadir\] at any time point during treatment) or failure to suppress HCV during treatment (all on-treatment values of HCV RNA ≥ LLOQ with at least 6 weeks of treatment).
Percentage of Participants With Post-treatment Relapse within 12 weeks after the last dose of study drug Relapse by post-treatment Week 12 was defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of study drug for a participant with HCV RNA \< LLOQ at the final treatment visit and who completed study treatment. Completion of treatment was defined as a study drug duration ≥ 77 days for the 12-week treatment arm or ≥ 105 days for the 16-week treatment arm.
Percentage of Participants With SVR12 Weeks Post-treatment for Each Treatment Arm Within Different Subpopulations 12 weeks after last dose of study drug The percentage of participants with SVR12 in each treatment arm within the following subpopulations: noncirrhotic participants; noncirrhotic treatment-experienced (T-exp) participants; noncirrhotic participants who relapsed after prior IFN-based therapy (relapsers); noncirrhotic T-exp participants who were non-responders to prior IFN-based therapy; noncirrhotic T-exp participants who were intolerant to IFN-based therapy; participants with compensated cirrhosis.