Phase 3
Completed N=94
5 Year Long-term Follow up in Pediatric Participants Who Received PegIntron Plus Rebetol in P02538 Part I (P02538 Pt 2)
Hepatitis C, Chronic
Source: ClinicalTrials.gov NCT00761735 ↗
Enrolled (actual)
94
Serious AEs
3.2%
Results posted
Dec 2013
Primary outcomePrimary: Number of Participants Who Relapsed At End of LTFU Year 5 — 0 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Relapsed At End of LTFU Year 5 |
— | — |
| PRIMARY Mean Height Percentiles of Participants Over LTFU |
48.94; 52.5; 49.21; 43.37; 50.56; 46.24 | — |
| PRIMARY Mean Weight Percentiles of Participants Over LTFU |
52.5; 58.56; 53.62; 56.38; 51.73; 52.03 | — |
| PRIMARY Mean Body Mass Index (BMI) Percentiles of Participants Over LTFU |
50.4; 59.76; 51.15; 59.91; 48.11; 52.89 | — |
| PRIMARY Mean Age at Attained Tanner Stages (Sexual Maturity) at End of LTFU (Last Observation) By Gender |
9.75; 11.00; 11.86; 12.53; 15.26; 13.60 | — |
Eligibility Criteria
Inclusion Criteria
- Informed consent must be obtained from the participant or the participant's parent or legal guardian prior to any long-term follow-up study-related procedures. According to local laws and/or IRB/IEC requirements, participants may also need to provide written assent.
- The participant must have received at least one dose of peginterferon alfa-2b and ribavirin in the Protocol No. P02538 study.
- The participant must have completed the 24-week post-treatment follow-up in the P02538 Part 1 study. All participants 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 participant unsuitable for enrollment.
Data sourced from ClinicalTrials.gov (NCT00761735). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.