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

NCT ID: NCT00221624

Last Updated: 2007-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

131 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-11-30

Study Completion Date

2004-04-30

Brief Summary

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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

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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.

Conditions

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HCV Infection Hepatitis C, Chronic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Peginterferon alfa-2a

Intervention Type DRUG

ribavirin

Intervention Type DRUG

amantadine

Intervention Type DRUG

Eligibility Criteria

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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

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role collaborator

University Hospital, Bordeaux

OTHER

Sponsor Role lead

Principal Investigators

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Patrice Couzigou, Pr

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Geneviève Chêne, Pr

Role: STUDY_CHAIR

University Hospital, Bordeaux

Locations

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Service d'hépato-Gastro-Entérologie - Hôpital Haut Leveque - avenue de Magellan

Pessac, , France

Site Status

Countries

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France

Other Identifiers

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2000-030

Identifier Type: -

Identifier Source: secondary_id

7929-01

Identifier Type: -

Identifier Source: org_study_id