Study on Chronic Hepatitis C Treatment With Interferon Alpha, Ribavirin and Amantadine in Naive Patients
* Adding Amantadine to standard anti-viral treatment can improve sustained response rates in patients with chronic hepatitis C
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Study on Chronic Hepatitis C Treatment With Interferon Alpha, Ribavirin and Amantadine in Naive Patients|
- Response rate at end of treatment and end of follow-up (sustained response rate)
|Study Start Date:||February 2000|
|Estimated Study Completion Date:||January 2007|
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.
|Utrecht, Netherlands, 3508 GA|
|Principal Investigator:||Karel v. Erpecum, MD, PhD||UMC Utrecht, dept. Gastroenterology|
|Principal Investigator:||Melvin Samsom, MD, PhD||UMC Utrecht, dept gastroenterology|