ong-Term Follow-Up of Subjects in a Phase 1, 2, or 3 Clinical Trial in Which Boceprevir or Narlaprevir was Administered for the Treatment of Chronic Hepatitis C.

Phase 3

Completed

Conditions: Chronic Hepatitis C
Hepatitis C virus infection
10047438

Registration Number: NL-OMON35269

Lead Sponsor: Schering-Plough

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 9

Inclusion Criteria

- Subject must be willing to give written informed consent and be able to adhere to the visit schedule.
- Subject must have received at least one dose of any study medication (peginterferon, ribavarin, boceprevir or narlaprevir) in a previous SPRI Phase 1, 2 or 3 clinical study in which Boceprevir or Narlaprevir was administered.

Exclusion Criteria

- Concurrent participation in any other clinical study for the treatment of chronic hepatitis C
- Retreatment with any antiviral or immunomodulatory drug for chronic hepatitis C after completion
of, or discontinuation from, the SPRI Phase 1, 2 or 3 clinical study in which the subject previously
participated.
- Any condition which in the opinion of the investigator would make the subject unsuitable for
enrollment.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint in this study is the durability of virologic response in<br /><br>subjects with chronic hepatitis C who were sustained responders at 24 weeks<br /><br>posttreatment in the previous study. A subject is classified as a sustained<br /><br>responder at a given time point if HCV-RNA is below the lower limit of<br /><br>detection at that time point.<br /><br><br /><br>In addition, the study will also characterize the following:<br /><br>* The long-term safety in subjects who received at least one dose of study<br /><br>medication in a previous Phase 1, 2 or 3 boceprevir of narlaprevir clinical<br /><br>study.<br /><br>* The natural history of HCV sequence variants in subjects who received at<br /><br>least one dose of study medication in a previous Phase 1, 2 or 3 boceprevir of<br /><br>narlaprevir clinical study.</p><br>

Secondary Outcome Measures