Actively Recruiting

Phase Not Applicable
Age: 6Months - 18Years
All Genders
NCT06183892

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

Age: 6Months - 18Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, China

Actively Recruiting

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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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