Ignite Creation Date:
2024-05-05 @ 5:02 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00378599
Status:
COMPLETED
Last Update Posted:
2017-04-06
First Post:
2006-09-18
Brief Title:
Effects of Pegylated Interferon Alfa-2b and Ribavirin After Orthotopic Liver Transplantation in Subjects With Chronic Hepatitis C Recurrence P04590AM3COMPLETED
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
PROTECT - Pegylated Interferon Alfa-2b and Ribavirin After Orthotopic Liver Transplantation Efficacy and Safety in Hepatitis C Recurrence Therapy
Status:
COMPLETED
Status Verified Date:
2017-03
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:
This is an exploratory study and is a Phase 3 single-arm multi-center open-label study of pegylated interferon alfa-2b PEG-IFN alpha-2b PEG-Intron and ribavirin RBV to determine the sustained virologic response SVR at 24-week follow-up to 48 week in subjects after orthotopic liver transplantation OLT with chronic hepatitis C HCV recurrence
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