Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00282256
Status:
COMPLETED
Last Update Posted:
2013-10-17
First Post:
2006-01-24
Brief Title:
A Study of a Modified-Release Tacrolimus Based Immunosuppression Regimen in Stable Pediatric Liver Transplant Patients
Sponsor:
Astellas Pharma Inc
Organization:
Astellas Pharma Inc
Study Overview
Official Title:
A Phase 2 Open-Label Multi-center Study to Assess the Pharmacokinetics Long-Term Safety and Tolerability of Tacrolimus in Stable Pediatric Liver Transplant Patients Converted From a Prograf Based Immunosuppression Regimen to a Modified Release MR Tacrolimus Based Immunosuppression Regimen
Status:
COMPLETED
Status Verified Date:
2013-08
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:
A study to assess the pharmacokinetics safety and effectiveness of tacrolimus in stable pediatric liver transplant patients converted from a Prograf based immunosuppression regimen to a modified release tacrolimus based immunosuppression regimen
Detailed Description:
A 1 arm study to assess the pharmacokinetics and long-term safety and effectiveness of a modified release tacrolimus based immunosuppression regimen in stable pediatric liver transplant patients converted from a Prograf based immunosuppression regimen
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