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

Phase 1

• Conditions: Chronic Hepatitis C; MedDRA version: 16.0 Level: PT Classification code 10008912 Term: Chronic hepatitis C System Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-05-28
• Study Completion: 2014-09-24
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 1243

Inclusion Criteria

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

Additional UK-specific contraception requirements (per Protocol Amendment 04):
(1) Acceptable methods of highly effective birth control for WOCBP include:
• Condom with spermicide
• Diaphragm and spermicide
• Cervical cap and spermicide
• Vasectomized male partner for a minimum of 6 months
(2) Two highly effective forms of contraception should be used by sexually active men and/or their partners if they are WOCBP.
(3) Acceptable methods of contraception for males are:
• Condom plus spermicide OR,
• Vasectomy for at least 6 months and with a history of confirmed azoospermia
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

Additional UK-specific requirements (per Protocol Amendment 04):
Subjects with ophthalmologic disorders considered clinically significant on eye (including retinal) exam.

Study & Design

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