Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2025-12-31 @ 7:52 AM
Study NCT ID:
NCT00761735
Status:
COMPLETED
Last Update Posted:
2017-04-04
First Post:
2008-09-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
5 Year Long-term Follow up in Pediatric Participants Who Received PegIntron Plus Rebetol in P02538 Part I (P02538 Pt 2)
Sponsor:
Merck Sharp & Dohme LLC
Organization:
Study Overview
Official Title:
Assessment of the Safety, Efficacy, Tolerability and Pharmacokinetics of PEG-Intron® Plus REBETOL® in Pediatric Patients With Chronic Hepatitis C
Status:
COMPLETED
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Study P02538 Part 2 is a 5-year long term follow-up (LTFU) study in pediatric participants who were treated with at least one dose of peginterferon alfa-2b (PEG-IFN) and ribavirin (RBV) and who completed the follow-up in the P02538 Part 1 study (NCT00104052). No study drug therapy will be administered during the P02538 Part 2 study. Durability of virologic response will be assessed for participants who attained sustained virologic response (SVR) in Part I of this study by performing annual Hepatitis C Virus ribonucleic acid (HCV-RNA) testing. In addition, this study will characterize long-term safety in all participants who received PEG-IFN plus RBV treatment.
Detailed Description:
During the Part 2 LTFU, participants will be evaluated at Years 1, 2, 3, 4, and 5. Each participant's first LTFU visit will be scheduled approximately 1 year after the post-treatment Follow-up Week 24 visit in Part 1 of this study (NCT00104052).
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2004-000558-22 | EUDRACT_NUMBER | None | View |