Prospective, Multicenter Clinical Study of Prolonged-release Tacrolimus in Stable Pediatric Liver Transplant Recipients

• Status: Not yet recruiting
• Trial end date: 2026-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: RenJi Hospital
• Treatments: Tacrolimus

Criteria

Inclusion Criteria:

1. Children (≤18 years old) who have undergone liver transplantation, with no gender limitations;

2. Able to completely swallow capsules;

3. Have been using immediate-release tacrolimus for at least three months prior to study enrollment;

4. Have normal blood count, liver and kidney function, coagulation function, and considered clinically stable by researchers;

5. Undergo a programmed liver biopsy;

Exclusion Criteria:

1. Multi-organ combined transplantation or multiple liver transplantation;

2. Adjuvant liver transplantation or use of bioartificial liver therapy;

3. ABO incompatible children with liver transplantation;

4. Allergic to tacrolimus;

5. Participation in any other clinical study within 3 months prior to enrollment;

6. Use of tacrolimus sustained release capsules before enrollment;

7. Tacrolimus trough concentration lower than 3.5 ng/ml at the time of screening;