A Phase 2B, randomized study to evaluate the safety and efficacy of Pegylated Interferon Lambda (BMS-914143) administered with Ribavirin plus a single direct antiviral agent (BMS-790052 or BMS-650032) versus Pegasys administered with Ribavirin (Part A) and of Pegylated Interferon Lambda (BMS-914143) administered with or without Ribavirin plus 2 direct antiviral agents (BMS 790052 and BMS-650032) (Part B) in chronic hepatitis C genotype-1 treatment na?ve subjects + Administrative Letter 01 (version 1.0, dated 10-Jan-11) - The D-LITE Study:Direct Antiviral Agents plus Lambda Interferon Treatment Evaluatio

• Conditions: Chronic Hepatitis C; MedDRA version: 9.1Level: LLTClassification code 10008912

• Registration Number: EUCTR2010-022568-11-IT
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02-21
• Last Update Posted: 14 September 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

•Chronic Hepatitis C, Genotype 1 •HCV RNA >100,000 IU/mL at screening; •Seronegative for HIV and HBsAg; •Liver biopsy within prior 2 years; subjects with compensated cirrhosis can enroll and will be capped at approximately 10%
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Any evidence of liver disease other than HCV; •Co-infection with HIV; •Diagnosed or suspected hepatocellular carcinoma; •Medical history or laboratory value abnormalities that would prohibit the use of Pegylated Interferon Alpha-2a or Ribavirin

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified