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

Hepatitis C, Chronic Clinical Trial

— PEGARI  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00221624
• Other study ID #: 7929-01
• Secondary ID: 2000-030
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: June 12, 2007
• Start date: November 2001
• Est. completion date: April 2004

Study information

• Verified date: June 2007
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: April 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HCV Infection
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic

Intervention

Drug:
• Peginterferon alfa-2a

• ribavirin

• amantadine

Locations

Country	Name	City	State
France	Service d’hépato-Gastro-Entérologie - Hôpital Haut Leveque - avenue de Magellan	Pessac

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Bordeaux	Hoffmann-La Roche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	ALT < upper limit of normal values,		24 weeks after the end of anti-HCV treatment
Secondary	histological response according to METAVIR score		24 weeks after the end of anti-HCV treatment
Secondary	adverse effects
Secondary	quality of life assessed		at week 72