Ignite Creation Date:
2024-05-05 @ 4:40 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00299923
Status:
UNKNOWN
Last Update Posted:
2007-03-09
First Post:
2006-03-06
Brief Title:
Study for Patients With Chronic HCV GT 1 or 3 Who Relapsed to Previous PegInterferon Ribavirin Combination Therapy
Sponsor:
University of Hamburg-Eppendorf
Organization:
Universitätsklinikum Hamburg-Eppendorf
Study Overview
Official Title:
Randomized Open-Label Multicenter Study Examining the Effects of Duration of Treatment of PEGASYS in Combination With Daily COPEGUS Amantadine in Patients With Chronic HCV After Relapse to Previous PegIFN Ribavirin Therapy
Status:
UNKNOWN
Status Verified Date:
2007-03
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
The aim of this study is to compare the relapse rate in chronic HCV patients with genotype 1 or 3 under the combination of standard dose Peg-Interferon alfa-2a PEG-IFN alfa-2a Ribavirin RBV and Amantadine AMA given for 72 weeks group A versus the same combination given for 48 weeks group B in patients who relapsed to previous combination therapy to conventional or pegylated PEG Interferon alfa and Ribavirin Relapse ist defined as percentage of patients with non-detectable HCV-RNA at end of therapy week 48 GT1 week 24 GT 3 who become HCV-RNA positive during a follow-up period of 24 weeks
Detailed Description:
None
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EudraCT-Nr 2005-001207-19 | None | None | None |