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High Dose Ribavirin in the Treatment of Chronic Hepatitis C

NCT00944684 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2011-11-11

No results posted yet for this study

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.

Conditions

  • Chronic Hepatitis C

Interventions

DRUG

High ribavirin dose

Ribavirin dose started according to kidney function (usually 1,800mg) and adapted according to plasma level during follow-up

DRUG

Standard ribavirin dose

Ribavirin dose started at 1,000mg (body weight \<65kg) or 1,200mg (body weight equal or \>65kg)

Sponsors & Collaborators

  • Roche Pharma AG

    collaborator INDUSTRY

  • University of Lausanne

    collaborator OTHER

  • Cantonal Hospital of St. Gallen

    collaborator OTHER

  • Waid City Hospital, Zurich

    collaborator OTHER

  • University of Basel

    collaborator OTHER

  • University of Bern

    lead OTHER

Principal Investigators

  • Felix Stickel, MD · Institute for Clinical Pharmacology and Visceral Research, University of Bern

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2011-04-30
Completion
2011-04-30

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00944684 on ClinicalTrials.gov