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Study for Patients With Chronic HCV (GT 1 or 3) Who Relapsed to Previous (Peg)Interferon/ Ribavirin Combination Therapy

NCT00299923 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2007-03-09

No results posted yet for this study

Summary

The aim of this study is, to compare the relapse rate in chronic HCV patients with genotype 1 or 3 under the combination of standard dose Peg-Interferon alfa-2a (PEG-IFN alfa-2a), Ribavirin (RBV) and Amantadine (AMA) given for 72 weeks (group A), versus the same combination, given for 48 weeks (group B) in patients who relapsed to previous combination therapy to conventional or pegylated (PEG) Interferon alfa and Ribavirin. Relapse ist defined as percentage of patients with non-detectable HCV-RNA at end of therapy (week 48 GT1/ week 24 GT 3) who become HCV-RNA positive during a follow-up period of 24 weeks.

Conditions

  • Hepatitis C, Chronic
  • Relapse

Interventions

DRUG

Peginterferon alfa-2a, Ribavirin, Amantadine

Sponsors & Collaborators

  • Universitätsklinikum Hamburg-Eppendorf

    collaborator OTHER

  • Hoffmann-La Roche

    collaborator INDUSTRY

  • University of Hamburg-Eppendorf

    lead OTHER

Principal Investigators

  • Peter Buggisch, Dr. · Universitätsklinikum Hamburg-Eppendorf, Medizinische Klinik 1

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-11-30

Countries

  • Germany

Study Locations

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Entities

Companies

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 NCT00299923 on ClinicalTrials.gov