Trial | NCT00221624  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    131
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.
Study Started
Nov 30
2001
Study Completion
Apr 30
2004
Last Update
Jun 13
2007
Estimate

Drug Peginterferon alfa-2a

Drug ribavirin

Drug amantadine

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
No Results Posted