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 (PEGARI)

NCT00221624 Phase 3 COMPLETED

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.

Details

Lead sponsor	University Hospital, Bordeaux
Phase	Phase 3
Status	COMPLETED
Enrolment	131
Start date	2001-11
Completion	2004-04

Conditions

• HCV Infection
• Hepatitis C, Chronic

Interventions

• Peginterferon alfa-2a
• ribavirin
• amantadine

Primary outcomes

• 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

Countries

France