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

September 13, 2005
June 12, 2007
November 2001
Not Provided
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 ]
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)
Complete list of historical versions of study NCT00221624 on ClinicalTrials.gov Archive Site
  • 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 ]
  • - 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
Not Provided
Not Provided
 
Peginterferon Alfa-2a Plus Ribavirin Plus Amantadine for the Treatment of Hepatitis C Infected Patients
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • HCV Infection
  • Hepatitis C, Chronic
  • Drug: Peginterferon alfa-2a
  • Drug: ribavirin
  • Drug: amantadine
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
131
April 2004
Not Provided

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00221624
7929-01, 2000-030
Yes
Not Provided
University Hospital, Bordeaux
Hoffmann-La Roche
Principal Investigator: Patrice Couzigou, Pr University Hospital, Bordeaux
Study Chair: Geneviève Chêne, Pr University Hospital, Bordeaux
University Hospital, Bordeaux
June 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP