Ignite Creation Date:
2024-05-05 @ 4:39 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00286871
Status:
COMPLETED
Last Update Posted:
2014-09-22
First Post:
2006-02-02
Brief Title:
Randomized Controlled Trial in Liver Transplant Recipients Treated in Steroid Sparing Regimen
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Steroid Avoidance in Hep C OLT
Status:
COMPLETED
Status Verified Date:
2006-02
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:
Liver transplant subjects will be given Mycophenolate MMF and Tacrolimus in order to help prevent post-transplant rejection
Detailed Description:
Recurrent HCV in the liver allograft is becoming the leading indicator for retransplantation Studies suggest that glucocorticord-based immunosuppression regimens hasten the onset and progression of recurrent chronic HCV liver disease Treatment of acute allograft rejection with steroid boluses is also associated with rapid HCV recurrence The relative contribution of various calcineurin inhibitors to recurrent HCV liver disease has not been established Previous retrospective studies as well as prospective studies have not demonstrated a difference in recurrent HCV liver disease rates between patients receiving CsA or tacrolimus immunosuppression regimens respectively
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 |
|---|---|---|---|
| 6538-04-11R0 | OTHER | Duke legacy protocol ID | None |