Phase 2 Safety Study of Pegylated Interferon Lambda plus single or 2 Direct Antiviral Agents with Ribarviri

• 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: EUCTR2010-022568-11-DE
• Lead Sponsor: Bristol Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01-31
• 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