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5 Year Long-term Follow up in Pediatric Participants Who Received PegIntron Plus Rebetol in P02538 Part I (P02538 Pt 2)

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatitis C, Chronic

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

Phase: Phase 3

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

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.

Clinical Details

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

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Number of Participants Who Relapsed At End of LTFU Year 5

Mean Height Percentiles of Participants Over LTFU

Mean Weight Percentiles of Participants Over LTFU

Mean Body Mass Index (BMI) Percentiles of Participants Over LTFU

Mean Age at Attained Tanner Stages (Sexual Maturity) at End of LTFU (Last Observation) By Gender

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).

Eligibility

Minimum age: 3 Years. Maximum age: 17 Years. Gender(s): Both.

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.

Locations and Contacts

Additional Information

Starting date: July 2007
Last updated: November 7, 2014

Page last updated: August 23, 2015

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