Phase III Hallmark QUAD: ASV+DCV+Peg+Rib (Nulls/Partials)
NCT01573351 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 398
Last updated 2015-10-09
Summary
The purpose of this study is to assess efficacy, as determined by the proportion of subjects with Sustained Virologic Response at Post-Treatment Week 12 (SVR12), defined as Hepatitis C virus (HCV) Ribonucleic acid (RNA) \< Limit of quantitation (LOQ) at post-treatment Week 12.
Conditions
- Hepatitis C Virus
Interventions
- DRUG
-
Asunaprevir
- DRUG
-
Daclatasvir
- DRUG
-
Peg-interferon Alfa-2a
- DRUG
-
Ribavirin
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Bristol-Myers Squibb · Bristol-Myers Squibb
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-05-31
- Primary Completion
- 2013-09-30
- Completion
- 2013-12-31
Countries
- United States
- Argentina
- Canada
- Denmark
- France
- Germany
- Italy
- Mexico
- Netherlands
- Russia
- South Korea
- Spain
- Sweden
- Switzerland
- Taiwan
Study Locations
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