5 Year Long-Term Follow up in Pediatric Subjects Who Received PegIntron Plus Rebetol in P02538 Part I (P02538 Pt2) - Full Text View

Sponsored by:	Schering-Plough
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00761735

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 III

MedlinePlus related topics: Hepatitis Hepatitis C

Drug Information available for: Ribavirin Interferon alfa-2b Peginterferon Alfa-2b

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Assessment of the Safety, Efficacy, Tolerability and Pharmacokinetics of PEG-Intron® Plus REBETOL® in Pediatric Patients With Chronic Hepatitis C

Further study details as provided by Schering-Plough:

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 ]

Estimated Enrollment:	100
Study Start Date:	July 2007
Estimated Study Completion Date:	May 2013
Estimated Primary Completion Date:	May 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: No Intervention 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. 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.

Arms

Assigned Interventions

1: No Intervention

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.

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.

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00761735

Contacts

Contact: SP Clinical Trial Registry Call Center

1-888-772-8734

Locations

Chile
Investigational Site 130	Recruiting
Santiago, Chile

Sponsors and Collaborators

Schering-Plough

More Information

Responsible Party:	Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers:	P02538: Part 2, 2004-000558-22
Study First Received:	September 5, 2008
Last Updated:	December 14, 2008
ClinicalTrials.gov Identifier:	NCT00761735
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Interferon-alpha
Liver Diseases
Hepatitis, Chronic
Interferons
Ribavirin
Hepatitis, Viral, Human
Hepatitis

Virus Diseases
Digestive System Diseases
Peginterferon alfa-2b
Hepatitis C
Interferon Alfa-2a
Hepatitis C, Chronic
Interferon Alfa-2b

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
RNA Virus Infections
Flaviviridae Infections
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances

Physiological Effects of Drugs
Antiviral Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents

ClinicalTrials.gov processed this record on January 14, 2009