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

University Hospital of Bordeaux

Status and phase: Completed; Phase 3

Conditions: Hepatitis C, Chronic; HCV Infection

Treatments: Drug: ribavirin; Drug: amantadine; Drug: Peginterferon alfa-2a

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00221624

2000-030

7929-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 131 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind