Actively Recruiting
Prospective, Multicenter Clinical Study of Prolonged-release Tacrolimus in Stable Pediatric Liver Transplant Recipients
Led by RenJi Hospital · Updated on 2024-12-18
80
Participants Needed
1
Research Sites
121 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Prospective, Multicenter Clinical Study of Prolonged-release Tacrolimus in Stable Pediatric Liver Transplant Recipients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 18 years or younger who have received a liver transplant
- Able to completely swallow capsules
- Using immediate-release tacrolimus for at least 3 months before joining the study
- Normal blood count, liver and kidney function, coagulation function, and clinically stable as judged by researchers
- Scheduled to undergo a programmed liver biopsy
You will not qualify if you...
- Have had multi-organ combined transplantation or multiple liver transplants
- Received adjuvant liver transplantation or bioartificial liver therapy
- Liver transplant with ABO blood type incompatibility
- Allergic to tacrolimus
- Participated in another clinical study within 3 months before joining
- Used tacrolimus sustained-release capsules before joining
- Tacrolimus trough concentration below 3.5 ng/ml at screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, China
Actively Recruiting
Research Team
H
Hao Feng, MD., Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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