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

RecruitingNAAges 6 Months - 18 YearsAllRenJi Hospital
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In plain words

What the trial is, and whether it could suit you

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.

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Children (โ‰ค18 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;
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What it tests

  • Tacrolimus Sustained-release Capsules
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Where

1 site
Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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