Conditions: Chronic Hepatitis C
Keywords: pediatric hepatitis children HCV PEG PEG-2a peginterferon alfa-2a Pegylated Interferon RV ribavirin Pegasys CHC chronic hepatitis C chronic hepatitis C virus hepatitis c pediatric hepatitis pediatric HCV
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 114
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine the safety and efficacy of peginterferon alfa-2a (PEG-2a) in combination with ribavirin (RV) and PEG-2a alone for the treatment of chronic hepatitis C virus (CHC) infection in children.

The purpose of this study is also to determine whether PEG-2a in combination with RV or PEG-2a alone will result in a longer response rate in children with CHC.

Detailed description:

Arms:
arm 1: Pegasys - 180 mcg per 1.73 meter squared body surface area subcutaneously once weekly.

Ribavirin - 15 mg per kg orally twice daily using 100-mg tablets. arm 2: Placebo tablets were supplied in the same dosing regimen as ribavirin, using the same number of tablets that would be given if ribavirin were being administered (eg, 3 placebo tablets twice daily for a 40-kg child who would receive 3 100-mg RV tablets twice daily).

Interventions: intervention 1: Pegylated Interferon/ribavirin
Intervention descriptions: intervention 1: None

Protocol document: