A Phase 3, Randomized, Double-Blind, Controlled Study Evaluating the Efficacy and Safety of Peginterferon Lambda-1a, with and without Daclatasvir, Compared to Peginterferon Alfa-2a, Each in Combination with Ribavirin, in the Treatment of Naïve Genotype 2 and 3 Chronic Hepatitis C Subjects;+ Pharmacogenetics Blood Sample Amendment Number 01 - Site Specific (version 1.0, dated 30-Mar12)
Phase 3
Completed
- Conditions
- Hepatitis CChronic HCVChronic Hepatitis C infection10047438
- Registration Number
- NL-OMON37644
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 8
Inclusion Criteria
* Chronic hepatitis C, Genotype 2 or 3;* Naïve to prior anti-HCV therapy
Exclusion Criteria
* Infected with HCV other than Genotype 2 or 3;* Positive HBsAg, or HIV-1/HIV-2 antibody;* Evidence of liver disease other than HCV ;* Active substance abuse;* Evidence of decompensated cirrhosis
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary efficacy endpoint is the proportion of chronically infected<br /><br>genotype 2 and 3 subjects who achieve SVR12</p><br>
- Secondary Outcome Measures
Name Time Method