CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 107 enrolled
Drug / intervention
peginterferon alfa-2b (PEG2b) (SCH 54031) +1 morebiological
Likely dose
Peginterferon alfa-2b 1.5 μg/kg/week subcutaneously once weekly plus ribavirin 15 mg/kg/day for 48 weeksAI-extracted
Key inclusion· 9
  • ✓Age 3-17 years old
  • ✓Body weight ≤90 kg
  • ✓Previously untreated chronic hepatitis C with detectable HCV RNA by qPCR
  • ✓Any HCV genotype allowed
Key exclusion· 18
  • ✕Previous hepatitis C treatment
  • ✕HBV or HIV co-infection
  • ✕Serum ALT >10× upper limit of normal in prior 6 months
  • ✕Liver disease not caused by hepatitis C or normal liver biopsy

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00104052
NCT00104052Phase 3Completed
CompareCT.gov

Assessment of the Safety, Efficacy, Tolerability and Pharmacokinetics of PEG-Intron® Plus REBETOL® in Pediatric Patients With Chronic Hepatitis C

Merck Sharp & Dohme LLC·interventional·Posted Feb 23, 2005·Updated Apr 4, 2017

In Brief

A Phase 3 clinical trial evaluating peginterferon alfa-2b (PEG2b) (SCH 54031) and ribavirin (SCH 18908) for Hepatitis C, Chronic. Completed, enrolled 107 participants.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C, Chronic
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 23, 2005
Enrollment StartFeb 1, 2005
Primary CompletionNov 1, 2007
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 21.4 years ago

Interventions

peginterferon alfa-2b (PEG2b) (SCH 54031)biological

PEG2b 1.5 μg/kg/wk given subcutaneously (once weekly) for 48 weeks.

ribavirin (SCH 18908)drug

15 mg/kg/day for up to 48 weeks