5 Year Long-term Follow up in Pediatric Participants Who Received PegIntron Plus Rebetol in P02538 Part I (P02538 Pt 2)
Status:
Completed
Trial end date:
2013-01-01
Target enrollment:
Participant gender:
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.