Study in Genotype 4 Subjects with Chronic Hepatitis C, evaluating BMS-790052 in combination with Peg-Interferon Alfa-2a and Ribaviri

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

• Registration Number: EUCTR2011-002793-23-GR
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04-02
• Last Update Posted: 10 March 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 172

Inclusion Criteria

• Subjects chronically infected with HCV Genotype 4
• HCV RNA viral load of = 10,000 IU/mL
• No previous exposure to an interferon formulation, RBV or HCV direct antiviral agent (DAA).
• Results of a liver biopsy obtained within three years prior to enrollment to demonstrate the absence of cirrhosis. Subjects with compensated cirrhosis are permitted, however, and any prior biopsy is permitted.

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 165
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 7

Exclusion Criteria

• Evidence of decompensated liver disease
• Documented or suspected HCC
• Positive for HBsAg or HIV-1/HIV-2 antibody at screening

Study & Design

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