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Sponsored by: |
Schering-Plough |
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Information provided by: | Schering-Plough |
ClinicalTrials.gov Identifier: | NCT00104052 |
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 |
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Hepatitis C, Chronic |
Drug: peginterferon alfa-2b (SCH 54031) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, 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 |
Estimated Enrollment: | 100 |
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 |
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PEG-Intron plus REBETOL: Experimental
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.
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Drug: peginterferon alfa-2b (SCH 54031)
60 µg/m2 subcutaneous injection once weekly for up to 48 weeks
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This global, multicenter, open-label Phase 1b/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.
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:
Responsible Party: | Schering-Plough ( Janice Albrecht, PhD - Vice President, Global Clinical Research, Hepatology ) |
Study ID Numbers: | P02538: Part 1 |
Study First Received: | February 22, 2005 |
Last Updated: | August 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00104052 |
Health Authority: | United States: Food and Drug Administration |
Virus Diseases Hepatitis Liver Diseases Digestive System Diseases Hepatitis, Chronic Ribavirin |
Peginterferon alfa-2b Hepatitis, Viral, Human Hepatitis C Interferon Alfa-2b Hepatitis C, Chronic |
Anti-Infective Agents RNA Virus Infections Flaviviridae Infections |
Therapeutic Uses Antiviral Agents Pharmacologic Actions |