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

This study has been completed.
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by:
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT00221624
First received: September 13, 2005
Last updated: June 12, 2007
Last verified: June 2007
  Purpose

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.


Condition Intervention Phase
HCV Infection
Hepatitis C, Chronic
Drug: Peginterferon alfa-2a
Drug: ribavirin
Drug: amantadine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by University Hospital, Bordeaux:

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) [ Time Frame: 24 weeks after the end of antiHCV treatment ]

Secondary Outcome Measures:
  • ALT < upper limit of normal values, [ Time Frame: 24 weeks after the end of anti-HCV treatment ]
  • histological response according to METAVIR score [ Time Frame: 24 weeks after the end of anti-HCV treatment ]
  • adverse effects
  • quality of life assessed [ Time Frame: at week 72 ]

Enrollment: 131
Study Start Date: November 2001
Study Completion Date: April 2004
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00221624

Locations
France
Service d’hépato-Gastro-Entérologie - Hôpital Haut Leveque - avenue de Magellan
Pessac, France, 33604
Sponsors and Collaborators
University Hospital, Bordeaux
Hoffmann-La Roche
Investigators
Principal Investigator: Patrice Couzigou, Pr University Hospital, Bordeaux
Study Chair: Geneviève Chêne, Pr University Hospital, Bordeaux
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00221624     History of Changes
Other Study ID Numbers: 7929-01, 2000-030
Study First Received: September 13, 2005
Last Updated: June 12, 2007
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Bordeaux:
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

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic
Amantadine
Interferons
Ribavirin
Peginterferon alfa-2a
Interferon-alpha
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Analgesics, Non-Narcotic

ClinicalTrials.gov processed this record on August 01, 2014