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

Primary Purpose

HCV Infection, Hepatitis C, Chronic

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Peginterferon alfa-2a
ribavirin
amantadine
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HCV Infection focused on measuring Hepatitis C, chronic, HCV infection, Treatment failure, PEG Interferon, (Interferons/therapeutic use, Interferon Alfa-2a/adverse effects), ribavirin, (Ribavirin/therapeutic use, Ribavirin/adverse effects), Amantadine, Drug Therapy, Combination

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

ALT < upper limit of normal values,
histological response according to METAVIR score
adverse effects
quality of life assessed

Full Information

First Posted
September 13, 2005
Last Updated
June 12, 2007
Sponsor
University Hospital, Bordeaux
Collaborators
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT00221624
Brief Title
Peginterferon Alfa-2a Plus Ribavirin Plus Amantadine for the Treatment of Hepatitis C Infected Patients
Acronym
PEGARI
Official Title
Randomized Placebo-Controlled Trial of a Triple Therapy Combining Peginterferon Alfa-2a Plus Ribavirin Plus Amantadine Versus Peginterferon Alfa-2a Plus Ribavirin Plus Placebo in Hepatitis C-Infected Patients Non Responders to a First-Line Therapy of Interferon and Ribavirin
Study Type
Interventional

2. Study Status

Record Verification Date
June 2007
Overall Recruitment Status
Completed
Study Start Date
November 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Bordeaux
Collaborators
Hoffmann-La Roche

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HCV Infection, Hepatitis C, Chronic
Keywords
Hepatitis C, chronic, HCV infection, Treatment failure, PEG Interferon, (Interferons/therapeutic use, Interferon Alfa-2a/adverse effects), ribavirin, (Ribavirin/therapeutic use, Ribavirin/adverse effects), Amantadine, Drug Therapy, Combination

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
131 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Peginterferon alfa-2a
Intervention Type
Drug
Intervention Name(s)
ribavirin
Intervention Type
Drug
Intervention Name(s)
amantadine
Primary Outcome Measure Information:
Title
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)
Time Frame
24 weeks after the end of antiHCV treatment
Secondary Outcome Measure Information:
Title
ALT < upper limit of normal values,
Time Frame
24 weeks after the end of anti-HCV treatment
Title
histological response according to METAVIR score
Time Frame
24 weeks after the end of anti-HCV treatment
Title
adverse effects
Title
quality of life assessed
Time Frame
at week 72

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrice Couzigou, Pr
Organizational Affiliation
University Hospital, Bordeaux
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Geneviève Chêne, Pr
Organizational Affiliation
University Hospital, Bordeaux
Official's Role
Study Chair
Facility Information:
Facility Name
Service d'hépato-Gastro-Entérologie - Hôpital Haut Leveque - avenue de Magellan
City
Pessac
ZIP/Postal Code
33604
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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