Safety and Efficacy Study of Pegylated Interferon Lambda with and without Daclatasvir, compared to Pegylated Interferon Alfa, plus Ribavirin in Subjects with Hepatitis C Genotype 2 and 3

• Conditions: Chronic Hepatitis C; MedDRA version: 14.1Level: PTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2011-004885-14-FI
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06-19
• Last Update Posted: 27 October 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1250

Inclusion Criteria

• Chronic hepatitis C, Genotype 2 or 3
• Naïve to prior anti-HCV therapy

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 1125
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 125

Exclusion Criteria

•Infected with HCV other than Genotype 2 or 3, mixed genotypes are
not allowed
• 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 clinical trial of medicinal product
• Study Design: Not specified