Three-year Follow-up Study of Subjects Who Participated in a Previous Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052) Chronic Hepatitis C Clinical Trial

Phase 1

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: EUCTR2011-005287-21-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: 1000

Inclusion Criteria

1. Received at least one dose of asunaprevir and/or daclatasvir and
completed participation in a previous study
a) Subjects participating in daclatasvir and/or asunaprevir studies may
enroll regardless of virologic response (subjects who received control
agents, eg, placebo, will be allowed to participate until unblinded
treatment information is released for the parent protocol; at that time
subjects will have the option to continue in the study)
b) Subjects participating in BMS-914143 (pegylated interferon lambda
1a) studies must have HCV RNA >=LOQ at the completion of the
posttreatment
follow-up period
2. Enrolled within 6 months of completing previous study or within 6
months of protocol availability at the clinical site
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 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 960

Exclusion Criteria

1. 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.<br>? 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): - Frequency of viral genotypic substitutions in subjects previously<br>treated with asunaprevir and/or daclatasvir who did not achieve or did<br>not maintain SVR12<br>- Long-term progression of liver disease, as measured by the frequency<br>of hepatic disease progression, all-cause mortality, and liver-related<br>mortality;Timepoint(s) of evaluation of this end point: - Assessed using resistance testing samples at 24-week intervals<br>- Assessed at 24-week intervals

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