Prospective, Multicenter Clinical Study of Prolonged-release Tacrolimus in Stable Pediatric Liver Transplant Recipients
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 6 months
Maximum Age: 18
Healthy Volunteers: f
View:
• 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;
Locations
Other Locations
China
Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
RECRUITING
Shanghai
Contact Information
Primary
Hao Feng, MD., Ph.D
surgeonfeng@live.com
008615000901110
Time Frame
Start Date: 2024-03-04
Estimated Completion Date: 2026-07-01
Participants
Target number of participants: 80
Treatments
Experimental: Prolonged-release tacrolimus
Related Therapeutic Areas
Sponsors
Leads: RenJi Hospital