RecruitingNot Applicable

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

China80 participantsStarted 2024-03-04

Plain-language 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.

Who can participate

Age range6 Months – 18 Years

SexALL

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Inclusion criteria

✓. 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;

Exclusion criteria

✕. 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;

What they're measuring

Incidence of biopsy-confirmed acute rejection (BPAR)

Timeframe: 12 months

Incidence of allograft liver fibrosis

Timeframe: 12 months

Trial details

NCT IDNCT06183892

SponsorRenJi Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-07-01

Contact for this trial

Hao Feng, MD., Ph.D

008615000901110 surgeonfeng@live.com

View on ClinicalTrials.gov More Liver Transplant trials