Overview
Phase 2b Study of BMS-986094 and Daclatasvir, With or Without Ribavirin for the Treatment of Patients With Chronic Hepatitis C
Status:
Withdrawn
Withdrawn
Trial end date:
2014-06-01
2014-06-01
Target enrollment:
0
0
Participant gender:
All
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 RibavirinPhase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Bristol-Myers SquibbTreatments:
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