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High Dose Versus Standard Dose of Ribavirin in Patients With Chronic Hepatitis C, Genotype 3

NCT00830609 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2012-03-13

No results posted yet for this study

Summary

The rate of sustained virological response (SVR) in patients with chronic hepatitis C, genotype 3, high viral load and without rapid virological response (RNA-HCV negative at week 4) is low. Standard of care of these patients include treatment with weekly peginterferon plus 800 mg/day of ribavirin (RBV). Extended treatment to 48 weeks does not provide more clinical benefit than the standard duration. The main hypothesis is that higher dose of ribavirin may be better in terms of SVR than the standard dose.

Conditions

  • Chronic Hepatitis C

Interventions

DRUG

Peginterferon alfa 2 A

Peginterferon alfa 2 A 180 mcg/week SC plus Ribavirin 800 mg/day po (Control Group) Peginterferon alfa 2 A 180 mcg/week SC plus Ribavirin 1,600 mg/day po plus Epoetin β (450 IU/kg/week) SC over 4 weeks (Arm B1) Peginterferon alfa 2 A 180 mcg/week SC plus Ribavirin 1,600 mg/day po plus Epo beta 450 UI over four weeks (Arm B1) If RNA-HCV positive at week 4, Peginterferon alfa 2 A 180 mcg/week SC plus Ribavirin 1,600 mg/day plus Epo beta 450 UI to keep Hb\>12 g/dL if required over 20 additional weeks (Arm B2)

DRUG

Peginterferon alfa 2 A, ribavirin + Epo Beta

Ribavirin 1,600 mg/day plus peginterferon alfa 2A 180 mcg/week plus Epo beta 450 IU/Kg/day to maintain Hb\>12g/dl over 4 or 24 weeks

DRUG

ribavirin

RBV 1600 mg/day 24 weeks

DRUG

ribavirin

ribavirin 800 mg/day for 24 weeks

DRUG

Peginterferon alfa 2

Peginterferon alfa 2 a 180 mcg/week for 4 weeks and then peginterferon alfa 2A for 20 weeks

DRUG

ribavirin

RBV 1600 mg/day 4 weeks and then ribavirin 800 mg/day 20 weeks

Sponsors & Collaborators

  • Dr. Conrado Fernandez

    lead OTHER

Principal Investigators

  • Conrado M Fernandez-Rodriguez · Hospital Universitario Fundacion Alcorcon; University Rey Juan Carlos.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2011-09-30
Completion
2011-12-31

Countries

  • Spain

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 NCT00830609 on ClinicalTrials.gov