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Triple Therapy With Peg-Interferon Alfa-2b/Ribavirin Plus Amantadine Compared to Standard Peg-Interferon Alfa-2b/Ribavirin for Previous Hepatitis C Virus (HCV) Non Responders

NCT00122629 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 405

Last updated 2005-07-29

No results posted yet for this study

Summary

Triple antiviral therapy with peg-interferon-alfa/ribavirin+amantadine was suggested to increase sustained virological response (SVR) rates in HCV non-responders to a standard interferon/ribavirin combination.

Patients with hepatitis C virus infection were eligible if they had failed to respond to a single previous 24 week cycle of interferon/ribavirin combination therapy. Non-response was defined as persistent HCV RNA in the serum during the last month of treatment.

This study tested the efficacy and safety of pegylated interferon alfa-2b with ribavirin and amantadine or a placebo for 48 weeks.

Conditions

  • Hepatitis C, Chronic

Interventions

DRUG

peg-interferon alfa-2b

DRUG

ribavirin

DRUG

amantadine

Sponsors & Collaborators

  • Schering-Plough

    collaborator INDUSTRY

  • French National Agency for Research on AIDS and Viral Hepatitis

    lead OTHER_GOV

Principal Investigators

  • Christian Trepo, MD · Hépato-Gastroentérologie Hopital Hôtel-Dieu LYON

  • P. ADELEINE, MD · Laboratoire d'Informatique Médicale Lyon

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2000-10-31
Completion
2003-05-31

Countries

  • France

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 NCT00122629 on ClinicalTrials.gov