Study of PEG-Intron Plus REBETOL in Pediatric Subjects With Chronic Hepatitis C (Study P02538 Part 1)
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|ClinicalTrials.gov Identifier: NCT00104052|
Recruitment Status : Completed
First Posted : February 23, 2005
Results First Posted : March 9, 2009
Last Update Posted : April 4, 2017
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
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 or disease||Intervention/treatment||Phase|
|Hepatitis C, Chronic||Biological: peginterferon alfa-2b (PEG2b) (SCH 54031) Drug: ribavirin (SCH 18908)||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||107 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Assessment of the Safety, Efficacy, Tolerability and Pharmacokinetics of PEG-Intron® Plus REBETOL® in Pediatric Patients With Chronic Hepatitis C|
|Study Start Date :||February 2005|
|Actual Primary Completion Date :||November 2007|
|Actual Study Completion Date :||November 2007|
Experimental: PEG-Intron alfa 2b (PEG2b) plus REBETOL (RBV)
PEG2b 1.5 μg/kg/wk given subcutaneously (once weekly) and RBV 400-1200 mg/day by mouth divided in 2 daily doses (administered twice daily with food, dosed 12 hours apart) for 48 weeks. Subjects treated up to 48 weeks and followed for additional 24 weeks after the end of treatment (total of 72 weeks study participation).
Biological: peginterferon alfa-2b (PEG2b) (SCH 54031)
PEG2b 1.5 μg/kg/wk given subcutaneously (once weekly) for 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)
Primary Outcome Measures :
- Number of Participants With a Sustained Virologic Response (SVR) at 24 Weeks Post-treatment [ Time Frame: Up to 48-week treatment duration. Follow-up of 24 weeks. ]SVR is defined as undetectable hepatitis C virus ribonucleic acid (HCV-RNA) at 24 weeks post-treatment
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