Ignite Creation Date:
2025-12-24 @ 5:34 PM
Ignite Modification Date:
2025-12-29 @ 2:20 AM
Study NCT ID:
NCT01339468
Status:
COMPLETED
Last Update Posted:
2017-07-19
First Post:
2011-04-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Assess the Pharmacokinetics, Safety and Efficacy of Advagraf and Prograf in de Novo Liver Transplantation
Sponsor:
Astellas Pharma Inc
Organization:
Study Overview
Official Title:
A Phase IV, Randomized, Open-label, Comparative, Single-center Study to Assess the Pharmacokinetics, Safety and Efficacy of Advagraf® (Modified Release Tacrolimus) and Prograf® (Tacrolimus) in de Novo Living Donor Liver Transplant Recipients
Status:
COMPLETED
Status Verified Date:
2017-07
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:
MAIN
Brief Summary:
The purpose of this study is to investigate and compare the pharmacokinetic parameters of tacrolimus from Advagraf and Prograf in de nove living donor liver transplant recipients.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: