Peginterferon Alfa-2a Plus Ribavirin Plus Amantadine for the Treatment of Hepatitis C Infected Patients

Phase 3

Completed

• Conditions: HCV Infection; Hepatitis C, Chronic

• Registration Number: NCT00221624
• Lead Sponsor: University Hospital, Bordeaux

Brief Summary

Response to a second-line anti-HCV treatment in non responder patients to a first-line dual therapy remains very poor. Preliminary studies of amantadine suggest that this drug could be potentially effective to treat hepatitis C.

Detailed Description

Background : Response to a second-line anti-HCV treatment in non responder patients to a first-line dual therapy remains very poor. Preliminary studies of amantadine suggest that this drug could be potentially effective to treat hepatitis C.

Design : randomized, double-blind, multicenter trial.

Interventions compared : Peg-interferon alfa 2A + ribavirin + amantadine versus Peg-interferon alfa 2A + ribavirin + Placebo

Eligibility criteria : Chronic hepatitis C, previously treated with combination of interferon plus ribavirin for at least 24 weeks,detectable HCV RNA.

primary outcome : sustained virological response, defined as an undetectable HCV RNA level 24 weeks after the end of anti HCV treatment.

Study Timeline

• Study Start: 2001-11
• Study Completion: 2004-04
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-22
• Status Verified: 2007-06
• Last Update Submitted: 2007-06-12
• Last Update Posted: 2007-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 131

Inclusion Criteria

• Chronic hepatitis C
• Previously treated with a combination of interferon plus ribavirin for at least 24 weeks
• Detectable HCV RNA (i.e. non responders)
• Signed informed consent

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Exclusion Criteria

• Evidence of another cause of liver disease
• Liver cirrhosis (child-Pugh stage BMC)
• Alcohol consumption > 30g/day for women or > 40g/day for men ; drug abuse
• Other serious relevant disorders : psychiatric condition (especially depression), cardio-vascular disease, renal decompensation, seizure history, hemoglobinopathy, auto-immune disease

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
sustained virological response, defined as an undetectable HCV RNA level 24 weeks after the end of anti HCV treatment (i.e. overall 72 weeks after randomization)	24 weeks after the end of antiHCV treatment

Secondary Outcome Measures

Name	Time	Method
ALT < upper limit of normal values,	24 weeks after the end of anti-HCV treatment
histological response according to METAVIR score	24 weeks after the end of anti-HCV treatment
adverse effects
quality of life assessed	at week 72

Trial Locations

Locations (1)

Service d'hépato-Gastro-Entérologie - Hôpital Haut Leveque - avenue de Magellan; 🇫🇷 Pessac, France