Study on Chronic Hepatitis C Treatment With Interferon Alpha, Ribavirin and Amantadine in Naive Patients
|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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00146016
|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|