Skip to main content
OpenTrials
Completed

NCT Number: NCT00221624

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

HCV Infection Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C Hepatitis C, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

Pessac, 33604, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Peginterferon alfa-2a

Drug

Ribavirin

Drug

Amantadine

Drug

Primary outcomes

  1. 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 outcomes

  1. ALT < upper limit of normal values,

    Time frame: 24 weeks after the end of anti-HCV treatment

  2. histological response according to METAVIR score

    Time frame: 24 weeks after the end of anti-HCV treatment

  3. adverse effects

  4. quality of life assessed

    Time frame: at week 72

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Collaborators

  • Hoffmann-La Roche

Registry information

Official study 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

Acronym: PEGARI

Important dates

Study start
2001
Study completion
2004
First posted
Sep 22, 2005
Registry last updated
Jun 13, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.