Prospective, Multicenter Clinical Study of Prolonged-release Tacrolimus in Stable Pediatric Liver Transplant Recipients
Recruiting now · Not applicable
Conditions studied: Liver Transplant
In brief
This study aims to explore the effects of tacrolimus sustained-release capsules on the incidence of biopsy-proven acute rejection(BPAR) and fibrosis in pediatric liver transplant recipients.
Key facts
- Study ID
- NCT06183892
- Run by
- RenJi Hospital
- People needed
- 80
- Starts
- 2024-03-04
- Expected to finish
- 2026-07-01
- Last updated by the study team
- 2024-12-18
Who can join
Age: 1 and older, up to 18. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Children (≤18 years old) who have undergone liver transplantation, with no gender limitations;
- Able to completely swallow capsules;
- Have been using immediate-release tacrolimus for at least three months prior to study enrollment;
- Have normal blood count, liver and kidney function, coagulation function, and considered clinically stable by researchers;
- Undergo a programmed liver biopsy;
You may not qualify if…
- Multi-organ combined transplantation or multiple liver transplantation;
- Adjuvant liver transplantation or use of bioartificial liver therapy;
- ABO incompatible children with liver transplantation;
- Allergic to tacrolimus;
- Participation in any other clinical study within 3 months prior to enrollment;
- Use of tacrolimus sustained release capsules before enrollment;
- Tacrolimus trough concentration lower than 3.5 ng/ml at the time of screening;
Where it is running
- Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University — Shanghai, China (enrolling)
Full record on ClinicalTrials.gov
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