Overview

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

Status:
Withdrawn
Trial end date:
2014-06-01
Target enrollment:
0
Participant gender:
All
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
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Bristol-Myers Squibb
Treatments:
Ribavirin
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