Phase 2b Study of BMS-986094 and Daclatasvir, With or Without Ribavirin for the Treatment of Patients With Chronic Hepatitis C
Phase 2
Withdrawn
- Conditions
- Hepatitis C Virus
- Interventions
- Registration Number
- NCT01629732
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to evaluate the effectiveness of BMS-986094 and Daclatasvir (DCV) when given in combination with or without Ribavirin
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1: Daclasasvir + BMS-986094 (100 mg) + Placebo Daclatasvir 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) Arm 4: Daclasasvir + BMS-986094 (200 mg) + Ribavirin BMS-986094 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) Arm 4: Daclasasvir + BMS-986094 (200 mg) + Ribavirin Ribavirin 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) Arm 3: Daclasasvir + BMS-986094 (100 mg) + Placebo + Ribavirin Ribavirin 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) Arm 6: Daclasasvir + BMS-986094 (200 mg) BMS-986094 Genotype 4 naive subjects Arm 5: Daclasasvir + BMS-986094 (200 mg) Daclatasvir Genotype 1 PI-failure subjects Arm 5: Daclasasvir + BMS-986094 (200 mg) BMS-986094 Genotype 1 PI-failure subjects Arm 6: Daclasasvir + BMS-986094 (200 mg) Daclatasvir Genotype 4 naive subjects Arm 1: Daclasasvir + BMS-986094 (100 mg) + Placebo Placebo for BMS-986094 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) Arm 3: Daclasasvir + BMS-986094 (100 mg) + Placebo + Ribavirin Placebo for BMS-986094 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) Arm 2: Daclasasvir + BMS-986094 (200 mg) Daclatasvir 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) Arm 3: Daclasasvir + BMS-986094 (100 mg) + Placebo + Ribavirin Daclatasvir 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) Arm 4: Daclasasvir + BMS-986094 (200 mg) + Ribavirin Daclatasvir 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) Arm 7: Daclasasvir + BMS-986094 (200 mg) Daclatasvir Genotype 2/3 NR/relapse Subjects Arm 1: Daclasasvir + BMS-986094 (100 mg) + Placebo BMS-986094 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) Arm 2: Daclasasvir + BMS-986094 (200 mg) BMS-986094 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) Arm 3: Daclasasvir + BMS-986094 (100 mg) + Placebo + Ribavirin BMS-986094 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) Arm 7: Daclasasvir + BMS-986094 (200 mg) BMS-986094 Genotype 2/3 NR/relapse Subjects
- Primary Outcome Measures
Name Time Method Proportion of subjects with SVR4 defined as HCV RNA < LOQ (25 IU/mL; detectable or undetectable) at 4 weeks post treatment to be evaluated in GT1 (naive and NR) subjects randomized to the 12-week treatment arm (arms 1a, 2a, 3a, 4a) Follow up Week 4 * SVR = Sustained virologic response
* HCV = Hepatitis C virus
* RNA = Ribonucleic acid
* LOQ = Limit of quantitation
- Secondary Outcome Measures
Name Time Method Proportion of treated subjects with SVR4 in genotype (GT) 1 naive and non-responder (NR) subjects randomized to the 24-week treatment arms (arms 1b, 2b, 3b, 4b) Follow up Week 4 (SVR4) Proportion of treated subjects with SVR4 in genotype 1 protease inhibitor (PI)failures, genotype 4 naive, and genotype 2/3 NR/relapse subjects (arms 5, 6, 7) Follow up Week 4 (SVR4) Proportion of treated subjects in each study population (GT1 naive, GT1 NR, or GT1 PI-failure, GT4 naive, GT2/3 NR/relapse), for each regimen and duration, who achieve HCV RNA < LOQ at post-treatment Post-treatment Week 2 (SVR2), Week 8 (SVR8), Week 12 (SVR12), Week 24 (SVR24), and Week 36 (SVR36, for the 12 week arms) Proportion of treated subjects in each study population, by regimen, who achieve HCV RNA < LOQ (detectable/undetectable) Weeks 1, 2, 4, 6, 8, 12 and End of Treatment (Week 12 or 24) Proportion of subjects in each study population, be regimen, who achieve HCV RNA undetectable Weeks 1, 2, 4, 6, 8, 12 and End of Treatment (Week 12 or 24) Safety and tolerability of BMS-986094 and DCV ± RBV as measured by the frequency of deaths, serious adverse events (SAEs), discontinuations due to Adverse Events (AEs), and severity Grade 3/4 laboratory abnormalities Up to post treatment Week 36
Trial Locations
- Locations (1)
Local Institution
🇺🇸Orlando, Florida, United States