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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00221624

Acronym

PEGARI

Enrollment

131

Registered

2005-09-22

Start date

2001-11-30

Completion date

2004-04-30

Last updated

2007-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HCV Infection, Hepatitis C, Chronic

Keywords

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

Brief summary

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.

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.

Interventions

DRUGPeginterferon alfa-2a

DRUGribavirin

DRUGamantadine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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)	24 weeks after the end of antiHCV treatment

Secondary

Measure	Time frame
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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026