Phase 2b Study of BMS-986094 and Daclatasvir, With or Without Ribavirin for the Treatment of Patients With Chronic Hepatitis C
Status and phase
Withdrawn
Phase 2
Conditions
Hepatitis C Virus
Treatments
Drug: Ribavirin
Drug: Placebo for BMS-986094
Drug: Daclatasvir
Drug: BMS-986094
Study type
Interventional
Funder types
Industry
Identifiers
Details and patient eligibility
About
The purpose of this study is to evaluate the effectiveness of BMS-986094 and Daclatasvir (DCV) when given in combination with or without Ribavirin
Sex
All
Ages
18+ years old
Volunteers
No Healthy Volunteers
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
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Quadruple Blind
0 participants in 7 patient groups
Arm 1: Daclasasvir + BMS-986094 (100 mg) + Placebo
Experimental group
Description:
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)
Treatment:
Drug: BMS-986094
Drug: Daclatasvir
Drug: Daclatasvir
Drug: Placebo for BMS-986094
Drug: BMS-986094
Drug: BMS-986094
Arm 2: Daclasasvir + BMS-986094 (200 mg)
Experimental group
Description:
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)
Treatment:
Drug: BMS-986094
Drug: Daclatasvir
Drug: Daclatasvir
Drug: BMS-986094
Drug: BMS-986094
Arm 3: Daclasasvir + BMS-986094 (100 mg) + Placebo + Ribavirin
Experimental group
Description:
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)
Treatment:
Drug: BMS-986094
Drug: Ribavirin
Drug: Daclatasvir
Drug: Daclatasvir
Drug: Placebo for BMS-986094
Drug: BMS-986094
Drug: BMS-986094
Arm 4: Daclasasvir + BMS-986094 (200 mg) + Ribavirin
Experimental group
Description:
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)
Treatment:
Drug: BMS-986094
Drug: Ribavirin
Drug: Daclatasvir
Drug: Daclatasvir
Drug: BMS-986094
Drug: BMS-986094
Arm 5: Daclasasvir + BMS-986094 (200 mg)
Experimental group
Description:
Genotype 1 PI-failure subjects
Treatment:
Drug: BMS-986094
Drug: Daclatasvir
Drug: Daclatasvir
Drug: BMS-986094
Drug: BMS-986094
Arm 6: Daclasasvir + BMS-986094 (200 mg)
Experimental group
Description:
Genotype 4 naive subjects
Treatment:
Drug: BMS-986094
Drug: Daclatasvir
Drug: Daclatasvir
Drug: BMS-986094
Drug: BMS-986094
Arm 7: Daclasasvir + BMS-986094 (200 mg)
Experimental group
Description:
Genotype 2/3 NR/relapse Subjects
Treatment:
Drug: BMS-986094
Drug: Daclatasvir
Drug: Daclatasvir
Drug: BMS-986094
Drug: BMS-986094
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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