5 Year Long-term Follow up in Pediatric Subjects Who Received PegIntron Plus Rebetol in P02538 Part I (P02538AM3 - Pt2)
This study has been completed.
Sponsor:
Merck
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00761735
First received: September 5, 2008
Last updated: January 30, 2013
Last verified: January 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatitis C, Chronic |
Biological: Peginterferon alfa-2b (SCH 54031) Drug: Ribavirin (SCH 18908) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Assessment of the Safety, Efficacy, Tolerability and Pharmacokinetics of PEG-Intron® Plus REBETOL® in Pediatric Patients With Chronic Hepatitis C |
Resource links provided by NLM:
Further study details as provided by Merck:
Primary Outcome Measures:
- 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.. ] [ Designated as safety issue: No ]
| Enrollment: | 107 |
| Study Start Date: | July 2007 |
| Study Completion Date: | January 2013 |
| Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: 1
Study P02538 Part 2 is a 5-year follow-up of pediatric subjects previously treated with peginterferon alfa-2b plus ribavirin (in P02538 Part 1). No study treatment will be administered in Study P02538 Part 2.
|
Biological: Peginterferon alfa-2b (SCH 54031)
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.
Other Name: PegIntron
Drug: Ribavirin (SCH 18908)
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.
Other Name: Rebetol
|
Eligibility| Ages Eligible for Study: | 3 Years to 24 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
No Contacts or Locations Provided
More Information
No publications provided by Merck
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Vice President of Late Stage Development, Merck Sharp & Dohme Corp |
| ClinicalTrials.gov Identifier: | NCT00761735 History of Changes |
| Other Study ID Numbers: | P02538: Part 2, 2004-000558-22 |
| Study First Received: | September 5, 2008 |
| Last Updated: | January 30, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis C Hepatitis C, Chronic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Flaviviridae Infections |
Hepatitis, Chronic Ribavirin Peginterferon alfa-2b Interferon-alpha Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antimetabolites Molecular Mechanisms of Pharmacological Action Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 18, 2013