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

Bristol-Myers Squibb

Overview

The purpose of this study is to evaluate the effectiveness of BMS-986094 and Daclatasvir (DCV) when given in combination with or without Ribavirin

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Conditions

Hepatitis C Virus

Interventions

DaclatasvirDRUG

Film coated tablet, Oral, 60 mg, Once daily, 12 or 24 weeks

DaclatasvirDRUG

Film coated tablet, Oral, 60 mg, Once daily, 24 weeks

BMS-986094DRUG

Capsule, Oral, 100 mg, Once daily, 12 or 24 weeks

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Local Institution

Orlando, Florida, United States

Outcomes

Primary Outcomes

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)

* SVR = Sustained virologic response * HCV = Hepatitis C virus * RNA = Ribonucleic acid * LOQ = Limit of quantitation

Time frame: Follow up Week 4

Secondary Outcomes

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)

Time frame: 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)

Time frame: 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

Time frame: 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)

Time frame: 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

Time frame: 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

Data from ClinicalTrials.gov

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