Clinical trial NCT00221624: Peginterferon Alfa-2a Plus Ribavirin Plus Amantadine for the Treatment of Hepatitis C Infected Patients
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
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
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
Collaborators: name: Hoffmann-La Roche
First posted: 2005-09-22
Enrollment: 131
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: 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)
timeFrame: 24 weeks after the end of antiHCV treatment
Secondary outcomes:
measure: ALT < upper limit of normal values,
timeFrame: 24 weeks after the end of anti-HCV treatment
measure: histological response according to METAVIR score
timeFrame: 24 weeks after the end of anti-HCV treatment
measure: adverse effects
measure: quality of life assessed
timeFrame: at week 72
Other outcomes:
Locations:
city: Pessac
country: France
facility: Service d'hépato-Gastro-Entérologie - Hôpital Haut Leveque - avenue de Magellan
Study officials:
affiliation: University Hospital, Bordeaux
name: Patrice Couzigou, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Bordeaux
name: Geneviève Chêne, Pr
role: STUDY_CHAIR
References: