Study on Chronic Hepatitis C Treatment With Interferon Alpha, Ribavirin and Amantadine in Naive Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00146016|
Recruitment Status : Completed
First Posted : September 5, 2005
Last Update Posted : September 5, 2005
|Condition or disease||Intervention/treatment||Phase|
|Chronic Hepatitis C||Drug: Amantadine||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||390 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Study on Chronic Hepatitis C Treatment With Interferon Alpha, Ribavirin and Amantadine in Naive Patients|
|Study Start Date :||February 2000|
|Estimated Study Completion Date :||January 2007|
- Response rate at end of treatment and end of follow-up (sustained response rate)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|