A Phase 3 Evaluation of Daclatasvir and Sofosbuvir With Ribavirin in Cirrhotic Subjects With Genotype 3 Chronic Hepatitis C Infection
Overview
- Phase
- Phase 3
- Intervention
- DCV
- Conditions
- Hepatitis C
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 106
- Locations
- 13
- Primary Endpoint
- Percentage of Participants With Sustained Virologic Response (SVR12)
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The purpose of this study is to determine whether 24 weeks of Daclatasvir and Sofosbuvir with Ribavirin is safe and effective in the treatment of genotype 3 hepatitis C infected patients with liver cirrhosis.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Genotype 3 HCV
- •HCV RNA ≥10000 IU (International Unit)/mL
- •Compensated Liver Cirrhosis
- •BMI 18-40 kg/m2
- •Previously treated for HCV or never treated for HCV
Exclusion Criteria
- •Infection with HCV other than Genotype
- •Mixed infection of any genotype
- •Evidence of decompensated liver disease
- •Previous exposure to NS5A inhibitors
- •Other protocol defined inclusion/exclusion criteria could apply
Arms & Interventions
Daclatasvir (DCV) + Sofosbuvir (SOF) + Ribavirin (RBV)
Oral dosing of DCV 60 mg tablet once daily + SOF 400 mg tablet once daily + RBV 1000-1200 mg tablet per day (weight based) for 24 weeks.
Intervention: DCV
Daclatasvir (DCV) + Sofosbuvir (SOF) + Ribavirin (RBV)
Oral dosing of DCV 60 mg tablet once daily + SOF 400 mg tablet once daily + RBV 1000-1200 mg tablet per day (weight based) for 24 weeks.
Intervention: SOF
Daclatasvir (DCV) + Sofosbuvir (SOF) + Ribavirin (RBV)
Oral dosing of DCV 60 mg tablet once daily + SOF 400 mg tablet once daily + RBV 1000-1200 mg tablet per day (weight based) for 24 weeks.
Intervention: RBV
Outcomes
Primary Outcomes
Percentage of Participants With Sustained Virologic Response (SVR12)
Time Frame: Week 12
SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target detected or target not detected at follow-up Week 12. HCV RNA measurements are excluded after the start of non-study anti-HCV medication on treatment or during follow-up. Modified (mITT) approach is based on treated subjects. The numerator is based on subjects meeting the response criteria and the Next Value Carried Backwards approach.
Secondary Outcomes
- Percentage of Subjects Who Achieve HCV RNA < LLOQ, TND Through Follow up Week 24(At Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, End of Treatment, Follow Up Week 4, Follow Up Week 12, Follow Up Week 24)
- Percentage of Subjects Who Achieve HCV RNA < LLOQ, TD or TND Through Follow up Week 24(At Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, End of Treatment (24 weeks), Follow Up Week 4 (28 weeks), Follow Up Week 12 (36 weeks), Follow Up Week 24 (48 weeks))
- Percentage of Participants Who Achieve SVR12 in the Presence and Absence of Baseline NS5A (Non-structural Protein 5A) Resistance-associated Polymorphisms(Week 12 (Follow-up period))