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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

Primary Purpose

Hepatitis C, Chronic

Status
Terminated
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
peg-interferon alfa-2b
ribavirin
amantadine
Sponsored by
French National Agency for Research on AIDS and Viral Hepatitis
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C, Chronic focused on measuring Hepatitis C, Chronic, peginterferon alfa-2b, ribavirin, Amantadine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)Does not accept healthy volunteers

Inclusion Criteria: Positive anti-HCV antibody test Patients who did not respond to treatment with standard interferon + ribavirin (HCV RNA+ by PCR in the last month of treatment) Compensated liver disease Neutrophil count over or equal to1000/mm3 Platelet count over or equal to 100 giga/L Haemoglobin over or equal to 10g/dL Patients had to have undergone a post-treatment liver biopsy within a year, showing a METAVIR histological score over or equal to A1F1, without cirrhosis (fibrosis score below F4) ALT over N and HCV RNA+ at screening Exclusion Criteria: Co-infection with hepatitis B or human immunodeficiency virus Any other cause of liver disease Active drug abuse, active alcohol consumption above 40g/day Organ grafts Presence of hepatocellular carcinoma Cardiovascular, metabolic, renal, haematological, neurological or psychiatric disease Patients with previous amantadine use Systemic immunosuppressive or antiviral treatment during the last 24 weeks and those with a history of interferon and/or ribavirin intolerance

Sites / Locations

  • Service d'Hépato-Gastroentérologie Hopital Hotel Dieu

Outcomes

Primary Outcome Measures

Sustained virological response, defined as an undetectable HCV-RNA 24 weeks after treatment discontinuation at week 72

Secondary Outcome Measures

Biochemical response at week 72 defined as ALT normalization
Histological benefit
Tolerance
Virological and biochemical responses during therapy at weeks 12, 24 and 48

Full Information

First Posted
July 20, 2005
Last Updated
July 28, 2005
Sponsor
French National Agency for Research on AIDS and Viral Hepatitis
Collaborators
Schering-Plough
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1. Study Identification

Unique Protocol Identification Number
NCT00122629
Brief Title
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
Official Title
Triple Therapy With Peg-Interferon Alfa-2b/Ribavirin Plus Amantadine Compared to Standard Peg-Interferon Alfa-2b/Ribavirin for Previous HCV Non Responders ANRSHC03 BITRI
Study Type
Interventional

2. Study Status

Record Verification Date
July 2005
Overall Recruitment Status
Terminated
Study Start Date
October 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2003 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
French National Agency for Research on AIDS and Viral Hepatitis
Collaborators
Schering-Plough

4. Oversight

5. Study Description

Brief 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.
Detailed Description
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. The aim of this study is to determine if the addition of amantadine to PEG-IFN/ribavirin enhances SVR. This study is a double blind, comparative, prospective multicenter, randomized study. Patients are recruited from 23 hepatology centers in France. The protocol was approved by the French ethical committee and all patients provided written informed consent. Eligible subjects are randomly assigned to the two treatment groups in equal proportions. The randomization process is generated by the Department of Biostatistics, Hospices Civils de Lyon, Lyon, France. Main inclusion criteria are: elevated ALT, detectable HCV RNA, Metavir score over or equal to A1F1 and below or equal to F3. Patients received PEG-IFN 1.5µg/kg/week, ribavirin 800-1200mg/day and amantadine 200mg/day or placebo during 48 weeks. The primary endpoint is a sustained virological response, defined as an undetectable HCV-RNA 24 weeks after treatment discontinuation (week 72). Secondary endpoints are the biochemical response at week 72 defined as ALT normalization; histological benefit; tolerance; and virological and biochemical responses during therapy at weeks 12, 24 and 48.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Chronic
Keywords
Hepatitis C, Chronic, peginterferon alfa-2b, ribavirin, Amantadine

7. Study Design

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

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
peg-interferon alfa-2b
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 24 weeks after treatment discontinuation at week 72
Secondary Outcome Measure Information:
Title
Biochemical response at week 72 defined as ALT normalization
Title
Histological benefit
Title
Tolerance
Title
Virological and biochemical responses during therapy at weeks 12, 24 and 48

10. Eligibility

Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Positive anti-HCV antibody test Patients who did not respond to treatment with standard interferon + ribavirin (HCV RNA+ by PCR in the last month of treatment) Compensated liver disease Neutrophil count over or equal to1000/mm3 Platelet count over or equal to 100 giga/L Haemoglobin over or equal to 10g/dL Patients had to have undergone a post-treatment liver biopsy within a year, showing a METAVIR histological score over or equal to A1F1, without cirrhosis (fibrosis score below F4) ALT over N and HCV RNA+ at screening Exclusion Criteria: Co-infection with hepatitis B or human immunodeficiency virus Any other cause of liver disease Active drug abuse, active alcohol consumption above 40g/day Organ grafts Presence of hepatocellular carcinoma Cardiovascular, metabolic, renal, haematological, neurological or psychiatric disease Patients with previous amantadine use Systemic immunosuppressive or antiviral treatment during the last 24 weeks and those with a history of interferon and/or ribavirin intolerance
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Trepo, MD
Organizational Affiliation
Hépato-Gastroentérologie Hopital Hôtel-Dieu LYON
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
P. ADELEINE, MD
Organizational Affiliation
Laboratoire d'Informatique Médicale Lyon
Official's Role
Study Chair
Facility Information:
Facility Name
Service d'Hépato-Gastroentérologie Hopital Hotel Dieu
City
Lyon Cedex
ZIP/Postal Code
69288
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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