High Dose Ribavirin in the Treatment of Chronic Hepatitis C
Status:
Completed
Trial end date:
2011-04-01
Target enrollment:
Participant gender:
Summary
Treatment of patients with chronic hepatitis C infected with genotype 1 hepatitis C virus
(HCV) consists of combined peginterferon/ribavirin for 48 weeks. Approximately 50% of
patients experience sustained virological response which equals cure. All other patients
either do not respond or experience recurrence of HCV virus and chronic hepatitis. Important
predictors of successful treatment are sustained dosing of both peginterferon and ribavirin.
With regard to the latter, clinical evidence indicates that higher ribavirin doses may in
fact even improve treatment outcome. However, high ribavirin doses cause hemolytic anemia
which require dose reductions. Recent clinical experience show that erythropoetic growth
factors, including erythropoetin, can counteract hemolytic anemia caused by antiviral
treatment in chronic hepatitis C patients. Therefore, the current trial aims to test whether
higher ribavirin doses adapted to a target plasma concentrations instead of a weight-based
dosing result in better healing rates, and whether ribavirin-associated hemolytic anemia can
be compensated by concommitant erythropoetin treatment.
Using a randomized, controlled, open-label design, the investigators hypothesize that
patients with high ribavirin doses adapted to plasma levels experience better viral clearance
than patients treated with standard weight-based ribavirin doses. In addition, the
investigators hypothesize that erythropoetin treatment will counteract hemolytic anemia
induced by ribavirin thereby allowing maintenance of target plasma concentrations without
ribavirin dose reductions.
Phase:
Phase 2
Details
Lead Sponsor:
University of Bern
Collaborators:
Cantonal Hospital of St. Gallen Roche Pharma AG University of Basel University of Lausanne Waid City Hospital, Zurich