Prospective, Multicenter Clinical Study of Prolonged-release Tacrolimus in Stable Pediatric Liver Transplant Recipients
NCT06183892 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80
Last updated 2024-12-18
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.
Conditions
- Liver Transplant
Interventions
- DRUG
-
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)
Sponsors & Collaborators
-
RenJi Hospital
lead OTHER
Principal Investigators
-
Qiang Xia, Prof. MD · Dept. Liver Surgery, Renji Hospital, School of Medicine, SJTU
-
Hao Feng, MD., Ph.D · Dept. Liver Surgery, Renji Hospital, School of Medicine, SJTU
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 6 Months
- Max Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-03-04
- Primary Completion
- 2025-07-01
- Completion
- 2026-07-01
Countries
- China
Study Locations
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