Phase 2b Study of BMS-986094 and Daclatasvir, With or Without Ribavirin for the Treatment of Patients With Chronic Hepatitis C
Hepatitis C Virus

About this trial
This is an interventional treatment trial for Hepatitis C Virus
Eligibility Criteria
Inclusion Criteria:
- Males and females, ≥ 18 years of age
- Subjects chronically infected with Hepatitis C virus (HCV) genotype 1,2,3 or 4
- HCV RNA viral load ≥ 10,000 IU/mL
- Subjects with compensated cirrhosis are permitted (compensated cirrhotics are capped at approximately 25% of treated population)
- Body Mass Index (BMI) of 18 to 35 kg/m2
- Seronegative for Hepatitis C virus (HIV) and Hepatitis B
Exclusion Criteria:
- Evidence of decompensated liver disease
- Evidence of medical condition contributing to chronic liver disease other than HCV
Sites / Locations
- Local Institution
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm 1: Daclasasvir + BMS-986094 (100 mg) + Placebo
Arm 2: Daclasasvir + BMS-986094 (200 mg)
Arm 3: Daclasasvir + BMS-986094 (100 mg) + Placebo + Ribavirin
Arm 4: Daclasasvir + BMS-986094 (200 mg) + Ribavirin
Arm 5: Daclasasvir + BMS-986094 (200 mg)
Arm 6: Daclasasvir + BMS-986094 (200 mg)
Arm 7: Daclasasvir + BMS-986094 (200 mg)
Subjects will be re-randomized at Week 12 to complete therapy at this visit and enter post-treatment follow-up, or continue therapy for an additional 12 weeks (24 weeks of therapy) Re-Randomized Arm 1 to Arm 1a and 1b (additional 12 weeks treatment)
Subjects will be re-randomized at Week 12 to complete therapy at this visit and enter post-treatment follow-up, or continue therapy for an additional 12 weeks (24 weeks of therapy) Re-Randomized Arm 2 to Arm 2a and 2b (additional 12 weeks treatment)
Subjects will be re-randomized at Week 12 to complete therapy at this visit and enter post-treatment follow-up, or continue therapy for an additional 12 weeks (24 weeks of therapy) Re-Randomized Arm 3 to Arm 3a and 3b (additional 12 weeks treatment)
Subjects will be re-randomized at Week 12 to complete therapy at this visit and enter post-treatment follow-up, or continue therapy for an additional 12 weeks (24 weeks of therapy) Re-Randomized Arm 4 to Arm 4a and 4b (additional 12 weeks treatment)
Genotype 1 PI-failure subjects
Genotype 4 naive subjects
Genotype 2/3 NR/relapse Subjects