drugset / Trial / NCT00485342

RIBAJUSTE Clinical Trial Investigating the Efficacy and Safety of Dose Adaptation of Ribavirin

NCT00485342

Phase 3 Unknown 236 enrolled Hospices Civils de Lyon
RandomizedParallel-groupOpen-labelTreatment

Summary

The aim of this study is to compare two therapeutical strategies concerning the combination therapy (peginterferon alfa-2a and ribavirin) in naïve patients with chronic hepatitis C of genotype 1. "Reference" strategy corresponding to standards of care recommended by the French consensus conference versus "Test" strategy corresponding to adaptation strategy of ribavirin dose during the first week according to AUC (area under the curve) of ribavirin plasmatic concentration after the first intake (Day 0) of 600 mg

Timeline

Start
2006-04
Primary completion
2013-03
Completion
2013-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Ribavirin Small molecule 1000 mg
Subject Ribavirin Small molecule 1200 mg
Comparator Peginterferon alfa-2a Protein / enzyme biologic 180 ug