Ignite Creation Date:
2024-05-05 @ 5:05 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00381017
Status:
WITHDRAWN
Last Update Posted:
2014-08-13
First Post:
2006-09-26
Brief Title:
Effects of Low-dose Maintenance Peg Interferon Alfa-2b Therapy Versus Supportive Care in Patients With Cirrhotic Hepatitis C With HIV Study P04371
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
A Randomized Open-label Multi-center Phase 3 2-arm Study Evaluating the Efficacy and Safety of Peg Interferon Alfa-2b Low-dose Maintenance Monotherapy Versus Standard Supportive Care in Patients With Cirrhotic Hepatitis C Co-infected With Human Immunodeficiency Virus - The ENDURE Study
Status:
WITHDRAWN
Status Verified Date:
2014-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Non-protocol feasibility
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Phase 3b randomized open-label parallel-group multi-center multi-national study of low-dose maintenance Peg interferon alpha-2b Peg-Intron in subjects with human immunodeficiency virus-hepatitis C virus HIV-HCV co-infection The primary objective is to compare at end of study the efficacy of Peg-Intron monotherapy 05 µgkg subcutaneously once weekly for 24-36 months versus standard supportive care using the time to any of the following clinical events death decompensation liver transplant hepatocellular carcinoma HCC as endpoints
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 NUMBER2005-003876-39 | None | None | None |