Study of pegInterferon Alfa-2a, Ribavirin, and Daclatasvir (BMS-790052) With or Without BMS-650032 for Participants in Some Hepatitis C Virus Trials
NCT01428063 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 276
Last updated 2016-05-27
Summary
The purpose of this study is to provide anti-hepatitis C virus drugs to patients who received placebo + peginterferon alfa-2a + ribavirin in prior Bristol-Myers Squibb (BMS) studies and determine whether addition of these drugs results in higher cure rates in patients who previously failed therapy. Approximately 100 genotype 1b patients who received placebo in BMS study NCT01428063 (AI447-028) will receive active drugs in this study.
Conditions
- Hepatitis C Virus Infection
Interventions
- DRUG
-
Daclatasvir
- DRUG
-
Asunaprevir
- DRUG
-
Pegylated interferon alfa-2a
- DRUG
-
Ribavirin
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Bristol-Myers Squibb · Bristol-Myers Squibb
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-09-30
- Primary Completion
- 2014-09-30
- Completion
- 2014-12-31
Countries
- United States
- Argentina
- Australia
- Austria
- Canada
- Denmark
- France
- Germany
- Greece
- Ireland
- Italy
- Mexico
- New Zealand
- Poland
- South Korea
- Spain
- Sweden
- Taiwan
- United Kingdom
Study Locations
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