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

Original Study ID : P02538: Part 2

Secondary ID : 2004-000558-22

NCT ID : NCT00761735

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

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

Brief Summary :

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.

Source : Schering-Plough

Overall Status : Recruiting

Start Date : July 2007

End Date : May 2013

Completion Date : May 2013

Official Title : Phase 3

Phase : Interventional

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

Enrollment : 100

Verification Date : May 2009

First Received Date : September 5, 2008

Trial Eligibility

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.

Gender : Both

Minimum Age : 3 Years

Maximum Age : 24 Years

Healthy Volunteers : No

Facilities

Facility Name : Investigational Site 130

Status : Recruiting

City : Santiago

Country : Chile

OutComes

Primary OutComes

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

Time Frame : 5-year long-term follow up study with visits scheduled at least once per year..

Safety issue : No

Interventions

Type : Biological

Name : Peginterferon alfa-2b (SCH 54031)

Description : Study P02538 Part 2 is a 5-year follow-up of previous combination treatment with peginterferon alfa-2b plus ribavirin. In the previous treatment protocol (P02538 Part 1), peginterferon alfa-2b was administered at a dose of 60 μg/m2 by subcutaneous injection QW.

Type : Drug

Name : Ribavirin (SCH 18908)

Description : Study P02538 Part 2 is a 5-year follow-up of previous combination treatment with peginterferon alfa-2b plus ribavirin. In the previous treatment protocol (P02538 Part 1), ribavirin was administered at a dose of 15 mg/kg/day orally in two divided doses.

Clinical Trial Name - 5 Year Long-Term Follow up in Pediatric Subjects Who Received PegIntron Plus Rebetol in P02538 Par