5 Year Long-term Follow up in Pediatric Subjects Who Received PegIntron Plus Rebetol in P02538 Part I (P02538 Pt2)

Condition(s) targeted: Hepatitis C, Chronic

Intervention: Peginterferon alfa-2b (SCH 54031) (Biological); Ribavirin (SCH 18908) (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Schering-Plough

Overall contact:
SP Clinical Trial Registry Call Center, Phone: 1-888-772-8734

Study P02538 Part 2 is a 5-year follow-up study in pediatric subjects who were treated with at least one dose of peginterferon alfa-2b and ribavirin and who completed the follow-up in the P02538 Part 1 study. No study drug therapy will be administered during the P02538 Part 2 study. Durability of virologic response will be assessed for subjects who attained SVR in Part I of this study by performing annual HCV-RNA testing In addition, this study will also characterize long-term safety in all subjects who received PegIntron plus Rebetol treatment.

Official title: Assessment of the Safety, Efficacy, Tolerability and Pharmacokinetics of PEG-Intron® Plus REBETOL® in Pediatric Patients With Chronic Hepatitis C

Study design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Primary outcome: Durability of the virologic response in pediatric subjects by measurement of HCV-RNA

Minimum age: 3 Years. Maximum age: 24 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Informed consent must be obtained from the subject or the subject's parent or legal

guardian prior to any long-term follow-up study-related procedures. According to local laws and/or IRB/IEC requirements, subjects may also need to provide written assent.

- The subject must have received at least one dose of peginterferon alfa-2b and

ribavirin in the Protocol No. P02538 study.

- The subject must have completed the 24-week post-treatment follow-up in the P02538

Part 1 study. All subjects whether sustained responders, relapsers, or nonresponders are eligible to participate.

Exclusion Criteria:

- Concurrent participation in any other clinical study.

- Retreatment with any antiviral or immunomodulatory drug for chronic hepatitis C after

completion of, or discontinuation from, the treatment phase of the P02538 Part 1 study.

- Any condition that in the opinion of the Investigator would make the subject

unsuitable for enrollment.

SP Clinical Trial Registry Call Center, Phone: 1-888-772-8734

Investigational Site 130, Santiago, Chile; Recruiting

Starting date: July 2007
Ending date: May 2013
Last updated: September 16, 2009