Ignite Creation Date:
2024-05-06 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06183892
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-28
First Post:
2023-06-22
Brief Title:
Prospective Multicenter Clinical Study of Prolonged-release Tacrolimus in Stable Pediatric Liver Transplant Recipients
Sponsor:
RenJi Hospital
Organization:
RenJi Hospital
Study Overview
Official Title:
Prospective Multicenter Clinical Study of Prolonged-release Tacrolimus in Stable Pediatric Liver Transplant Recipients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-12
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 study aims to explore the effects of tacrolimus sustained-release capsules on the incidence of biopsy-proven acute rejectionBPAR and fibrosis in pediatric liver transplant recipients
Detailed Description:
Tacrolimus is a commonly used immunosuppressant after liver transplantation However with increased postoperative time and a decline in postoperative compliance some children may miss medication leading to acute rejection Repeated rejection can cause fibrosis of the transplanted liver seriously impacting graft function and even postoperative survival sometimes resulting in the need for a second liver transplant In adult liver transplant recipients tacrolimus sustained-release capsules have been shown to significantly improve overall and transplanted liver survival compared to conventional formulations immediate-release tacrolimustaken twice daily Therefore this study aims to explore the effects of tacrolimus sustained-release capsules on the incidence of biopsy-proven acute rejectionBPAR and fibrosis in pediatric liver transplant recipients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None