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| Sponsor: | Schering-Plough |
|---|---|
| Information provided by: | Schering-Plough |
| ClinicalTrials.gov Identifier: | NCT00104052 |
Purpose
The primary objective is to assess the safety, efficacy and tolerability of the combination of PEG-Intron plus REBETOL in pediatric subjects with chronic hepatitis C. The secondary objective is to measure the multiple-dose pharmacokinetics of PEG-Intron and REBETOL in pediatric subjects with chronic hepatitis C.
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatitis C, Chronic |
Biological: peginterferon alfa-2b (SCH 54031) Drug: ribavirin (SCH 18908) |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: 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 |
| Enrollment: | 107 |
| Study Start Date: | February 2005 |
| Study Completion Date: | November 2007 |
| Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: PEG-Intron plus REBETOL
SCH 54031 PEG-Intron (peginterferon alfa-2b) 60 µg/m2 subcutaneous injection once weekly plus SCH 18908 REBETOL (ribavirin) 15 mg/kg PO daily in two divided doses for 48 weeks for subjects with Genotypes 1,4,5,6 and high-viral-load (≥600,000 IU/mL) Genotype 3 subjects. For subjects with Genotype 2 or low-viral-load Genotype 3 (<600,000 IU/mL), the same treatment will be given for 24 weeks.
|
Biological: peginterferon alfa-2b (SCH 54031)
60 µg/m2 subcutaneous injection once weekly for up to 48 weeks
Other Name: PEG-Intron (SCH 54031)
Drug: ribavirin (SCH 18908)
15 mg/kg/day for up to 48 weeks
Other Name: REBETOL (SCH 18908)
|
This global, multicenter, open-label Phase 3 study will evaluate the safety, efficacy and tolerability of PEG-Intron plus REBETOL in previously untreated pediatric subjects, ages 3 through 17 years, with chronic hepatitis C.
Eligibility| Ages Eligible for Study: | 3 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Hematology laboratory results of:
Chemistry laboratory results of:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough |
| ClinicalTrials.gov Identifier: | NCT00104052 History of Changes |
| Other Study ID Numbers: | P02538: Part 1 |
| Study First Received: | February 22, 2005 |
| Results First Received: | November 14, 2008 |
| Last Updated: | October 13, 2009 |
| Health Authority: | United States: Food and Drug Administration |
|
Hepatitis Hepatitis A Hepatitis, Chronic Hepatitis C Hepatitis C, Chronic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Flaviviridae Infections Interferon Alfa-2b Ribavirin |
Peginterferon alfa-2b Interferon-alpha Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antiviral Agents Anti-Infective Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Antimetabolites Molecular Mechanisms of Pharmacological Action Immunologic Factors |