Study in Genotype 1 and 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-IT

Lead Sponsor: BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATIO

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 557

Inclusion Criteria

• Subjects chronically infected with HCV Genotype 1 or 4. • HCV RNA viral load of = 10,000 IU/mL. • No previous exposure to an interferon formulation, RBV or HCV direct antiviral agent. • 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: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 535
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 22

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare rates of SVR12 for Genotype 1 subjects treated with either BMS-790052 or placebo in combination with pegIFNa-2a/RBV.;Secondary Objective: • To estimate the difference in rates of SVR12 for HCV Genotype 4 subjects treated with either BMS-790052 or placebo in combination with pegIFNa-2a/RBV. • For HCV Genotype 1 or Genotype 4 subjects, assess efficacy. • To assess safety, as measured by the frequency of Serious Adverse Events (SAEs) and discontinuations due to AEs for each cohort. • To assess the relationship between efficacy endpoints and the rs12979860 single nucleotide polymorphisms (SNP) in the IL28B gene.;Primary end point(s): To compare rates of SVR12 for HCV Genotype 1 subjects treated with either BMS-790052 or placebo in combination with pegIFNa-2a/RBV.;Timepoint(s) of evaluation of this end point: Week 12 follow up

Secondary Outcome Measures