Three-year Follow-up Study of Subjects Who Participated in a Previous BMS-650032 or BMS-790052 Chronic Hepatitis C Clinical Trial
Phase 1
- 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
- EUCTR2011-005287-21-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
- 1000
Inclusion Criteria
completed participation in a previous study of BMS-650032 and/or BMS- 790052 (NOTE: Subjects who received control agents [eg, placebo] in the previous study will be allowed to participate until unblinded data are released) - Enrolled within 6 months of completing previous study or within 6 months of protocol availability
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 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 960
Exclusion Criteria
Treatment with any antiviral or immunomodulatory drug for hepatitis C after completion of the previous study
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine the durability of virologic response in subjects previously treated with BMS-650032 and/or BMS-790052 who achieved Sustained Virologic Response (SVR12) in the previous study.;Secondary Objective: • To assess the presence of HCV sequence variants over time in subjects previously treated with BMS-650032 and/or BMS-790052 who did not achieve SVR12 or relapsed after achieving SVR12 in the previous study. • To characterize the long-term progression of liver disease, as measured by the frequency of hepatic disease progression, all-cause mortality, and liver-related mortality, among subjects previously treated with BMS-650032 and/or BMS-790052.;Primary end point(s): The durability of virologic response, as assessed by the time to loss of virologic response after achieving sustained viral response (SVR12) in a previous study with BMS-650032 and/or BMS-790052.;Timepoint(s) of evaluation of this end point: Loss of virologic response assessed using HCV RNA at 24-week intervals
- Secondary Outcome Measures
Name Time Method Secondary end point(s): In subjects previously treated with BMS-650032 and/or BMS-790052: - Frequency of viral genotypic substitutions in those who did not achieve or did not maintain SVR12 - Frequency of hepatic disease progression, all-cause mortality, liverrelated mortality;Timepoint(s) of evaluation of this end point: - Assessed using resistance testing samples at 24-week intervals - Assessed at 24-week intervals