Tacrolimus Sustained-release Capsules: Immediate-release tacrolimus for at least 3 months after liver transplantation, and then convert to tacrolimus sustained-release capsules at a ratio of 1:1 to 1:1.2; Take the medicine once a day on an empty stomach in the morning.
(The specific medication plan is decided by the clinician according to the actual situation)
Study 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.
Eligibility
Sex
ALL
Min age
6 Months
Max age
18 Years
Healthy volunteers
No
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;
Primary outcome measure(s)
Incidence of biopsy-confirmed acute rejection (BPAR) — 12 months biopsy-confirmed acute rejection (BPAR) would be evaluated by the international Banff classification
Incidence of allograft liver fibrosis — 12 months allograft liver fibrosis would be evaluated by LAFSc
Trial sites (1)
Facility
City
Region
Status
Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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