An Open-label Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) Co-administered With Ribavirin (RBV) for 12 or 16 Weeks in Treatment-Naïve and Treatment-Experienced Japanese Adults With Genotype 2 Chronic Hepatitis C Virus (HCV) Infection With and Without Compensated Cirrhosis (GIFT-II)
Overview
- Phase
- Phase 3
- Intervention
- ABT-450/r/ABT-267
- Conditions
- Hepatitis C Virus
- Sponsor
- AbbVie
- Enrollment
- 171
- Primary Endpoint
- Percentage of Non-cirrhotic, Treatment-naive Participants in Each Treatment Group With a Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
ABT-450/r/ABT-267 plus RBV for 12 weeks
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
Intervention: ABT-450/r/ABT-267
ABT-450/r/ABT-267 plus RBV for 12 weeks
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
Intervention: Ribavirin
ABT-450/r/ABT-267 plus RBV for 16 weeks
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
Intervention: ABT-450/r/ABT-267
ABT-450/r/ABT-267 plus RBV for 16 weeks
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
Intervention: Ribavirin
Outcomes
Primary Outcomes
Percentage of Non-cirrhotic, Treatment-naive Participants in Each Treatment Group With a Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
Time Frame: 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 Outcomes
- 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))
- Percentage of Participants With Post-treatment Relapse Within Different Subpopulations(within 12 weeks after the last dose of study drug)
- Percentage of Participants in Each Treatment Arm With On-treatment Virologic Failure During the Treatment Period(12 or 16 weeks (end of treatment period))
- Percentage of Participants With Post-treatment Relapse(within 12 weeks after the last dose of study drug)
- Percentage of Participants With SVR12 Weeks Post-treatment for Each Treatment Arm Within Different Subpopulations(12 weeks after last dose of study drug)