Study in Genotype 4 Subjects with Chronic Hepatitis C, evaluating BMS-790052 in combination with Peg-Interferon Alfa-2a and Ribaviri
- Conditions
- Chronic Hepatitis CMedDRA version: 14.1Level: LLTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2011-002793-23-ES
- Lead Sponsor
- Bristol-Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 152
? 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
? 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
- Secondary Outcome Measures
Name Time Method