MAGNITUDE-A Phase 3 Evaluation of the Safety and Efficacy of Lambda/RBV/DCV in Treatment Naïve Subjects with Chronic HCV Infection, who have Underlying Mild or Moderate Hemophilia or Patients who are Prior Relapsers to Pegylated interferon alfa/RBV;Revised Protocol 01 Incorporates Amendment 02 and Administrative Letter 01 and 02;+ Pharmacogenetics Blood Sample Amendment Number 01 - Site Specific (version 1.0, dated 11-Sep-12)
Phase 3
Completed
- Conditions
- Chronic HepatitisHemophilia100644771001965410047438
- Registration Number
- NL-OMON39678
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
Inclusion Criteria
• Infection with the hepatitis C virus (HCV) with underlying mild or moderate hemophilia;• Males 18 years of age and above ;• Have not been previously treated with an interferon
Exclusion Criteria
• Not infected with the hepatitis C virus (HCV), hepatitis D virus (HDV) or human immunodeficiency virus (HIV);• Do not have a serious liver, psychiatric, blood, thyroid, lung, heart or eye disease;• Presence of Bethesda inhibitor
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary objective for this study is to evaluate the proportion of subjects<br /><br>who achieve SVR12 (HCV RNA < LLOQ (target not detected) at post-treatment<br /><br>follow-up Week 12 in subjects with GT-1b, -4 and GT-2, -3.</p><br>
- Secondary Outcome Measures
Name Time Method