Ignite Creation Date:
2024-05-05 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00459719
Status:
COMPLETED
Last Update Posted:
2016-02-24
First Post:
2007-04-10
Brief Title:
A Study to Compare the Efficacy and Safety of FK506MR vs Prograf in Patients Undergoing Liver Transplantation
Sponsor:
Astellas Pharma Inc
Organization:
Astellas Pharma Inc
Study Overview
Official Title:
A Multicenter Randomized Open Label Parallel Study to Evaluate and Compare the Efficacy and Safety of FK506MR vs Prograf in Combination With Steroids in Patients Undergoing Liver Transplantation and a Pharmacokinetics Study
Status:
COMPLETED
Status Verified Date:
2016-02
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:
The patients about to undergo liver transplantation will be randomized to one of the following two group
Group FK506MR FK506MRsteroid Group Prograf Prograf steroid The treatment period is 3 months12 weeks
Group FK506MR FK506MRsteroid Group Prograf Prograf steroid The treatment period is 3 months12 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