NCT00146016

Study on Chronic Hepatitis C Treatment With Interferon Alpha, Ribavirin and Amantadine in Naive Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 390 (planned)
• Sponsor: UMC Utrecht · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

\* Adding Amantadine to standard anti-viral treatment can improve sustained response rates in patients with chronic hepatitis C

Detailed description

The CIRA-study is a double blind, placebo controlled, randomised, multicentre study in previously untreated patients suffering from chronic hepatitis C comparing double therapy, consisting of (PEG-)interferon alpha 2b ((PEG)Intron-A®) and ribavirin (Rebetol®), with triple therapy, consisting of (PEG-)interferon alpha 2b, ribavirin and amantadine, for 52 weeks. Follow-up is completed at week 104. 150 Subjects per treatment group will be included. Patients will be stratified before randomisation according to genotype (1 versus non-1). Viral load will not be a discriminating factor. The aim is to investigate the efficacy of the adjunct amantadine to the currently used combination therapy with interferon alpha and ribavirin.

Conditions

• Chronic Hepatitis C

Interventions

Type	Name	Description
DRUG	Amantadine

Timeline

• Start date: 2000-02-01
• Completion: 2007-01-01
• First posted: 2005-09-05
• Last updated: 2005-09-05

Locations

1 site across 1 country: Netherlands