A Long-Term Follow-Up Study of Subjects Who Participated in a Clinical Trial in which Peginterferon Lambda 1-a (BMS-914143) was Administered for the Treatment of Chronic Hepatitis C

Phase 3

Completed

Conditions: Hepatitis C
Chronic HCV
Chronic Hepatitis C Infection
10047438

Registration Number: NL-OMON40600

Lead Sponsor: Bristol-Myers Squibb

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 26

Inclusion Criteria

Subjects must have received BMS-914143 in a previous trial and have HCV RNA < LOQ at the completion of the required post-treatment follow-up (must enter this study within 6 months of completion of the required post-treatment follow-up in the previous trial).

Exclusion Criteria

Subjects must not have been treated with any antiviral or immunomodulatory drug for hepatitis C after completion of the previous study of BMS-914143.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary: To determine the durability of virologic response in subjects treated<br /><br>in a previous study with Peginterferon lambda 1-a (BMS-914143; Lambda) with or<br /><br>without ribavirin (RBV) and/or direct acting antiviral agents (DAAs), who have<br /><br>HCV RNA less than the limit of quantitation of the assay (< LOQ) at the<br /><br>completion of the required post-treatment follow-up in the previous (parent)<br /><br>study.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary:<br /><br>To characterize the long-term progression of liver disease, as measured by<br /><br>laboratory indicators of hepatic status and function, all-cause mortality, and<br /><br>liver-related mortality, among subjects previously treated with Lambda<br /><br>(BMS-914143) with or without RBV and/or DAAs, who have HCV RNA <LOQ at the<br /><br>completion of the required post-treatment follow-up in the parent study<br /><br>To determine the duration of persistence of anti-Lambda antibodies in subjects<br /><br>who are positive for anti-Lambda antibodies at end of treatment (EOT) in the<br /><br>parent study</p><br>