Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00146016
Status:
COMPLETED
Last Update Posted:
2005-09-05
First Post:
2005-09-01
Brief Title:
Study on Chronic Hepatitis C Treatment With Interferon Alpha Ribavirin and Amantadine in Naive Patients
Sponsor:
UMC Utrecht
Organization:
UMC Utrecht
Study Overview
Official Title:
Study on Chronic Hepatitis C Treatment With Interferon Alpha Ribavirin and Amantadine in Naive Patients
Status:
COMPLETED
Status Verified Date:
2005-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 PEGIntron-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
The aim is to investigate the efficacy of the adjunct amantadine to the currently used combination therapy with interferon alpha and ribavirin
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None