RecruitingNot ApplicableNCT05308628

Pediatric Liver Transplantation-Liver Fibrosis Evaluation by Using Fibrosis Panel

Effect of the Fibrosis Panel on the Evaluation of Allograft Fibrosis After Pediatric Liver Transplantation

Sponsor

RenJi Hospital

Enrollment

1,200 participants

Start Date

Apr 30, 2022

Study Type

INTERVENTIONAL

Conditions

Liver Transplant; Complications Liver Fibrosis Pediatric Disorder

Summary

Liver transplantation in children is highly successful with \>80% having 20 years survival. Most pediatric liver diseases are potentially curable with liver transplantation and it is important to establish whether children who have undergone successful transplantation can expect a normal life expectancy or whether there will be a gradual decline in liver function and eventual graft loss. The most common reasons in late graft loss in children are unexplained graft inflammation ("idiopathic" post-transplant hepatitis) and graft fibrosis. PRO-C3, a disintegrin and metalloproteinase with thrombospondin motifs-generated neo-epitope marker of type III collagen formation, has been proved to be a marker of fibrosis in patients with NAFLD. The aim of this study is to explore the role of Fibrosis Panel(PRO-C3, PIIINP, TIMP-1, HA) in children received liver transplantation.

Eligibility

Min Age: 2 MonthsMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study monitors liver health in children who received a liver transplant by tracking blood-based markers of liver fibrosis (scarring) over time. This study aims to see if blood tests (a fibrosis panel) can reliably track liver health without repeated biopsies. You may be eligible if: - Your child is between 8 weeks and 18 years old - Your child received their first liver transplant (from a deceased or living donor) - They received only a liver (no other organs) - You as a parent or guardian can understand and sign the consent form You may NOT be eligible if: - The child is over 18 years old - The child is pregnant or breastfeeding - There is an active systemic infection - The child has received or is receiving a repeat liver transplant or multiple organ transplant - The child has multi-organ failure - The child has congenital heart, lung, kidney, nervous system, or blood disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DIAGNOSTIC_TESTLiver Allograft Fibrosis by Using Fibrosis Panel(PRO-C3, PIIINP, TIMP-1, HA etc.)

Liver biopsies will be performed at 3 months, 6 months and 12 months post-transplant. Fibrosis was evaluated using the liver allograft fibrosis score (LAFSc) staging system. Liver Allograft Fibrosis by Using Fibrosis Panel(PRO-C3, PIIINP, TIMP-1, HA)or (FBLN3,YKL40,LECT2 etc.)

Locations(2)

Deparment of Liver Surgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, China

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

Shanghai, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05308628

Related Trials

Correlation Of EUS-SWQ And Liver Fibrosis Pathology In Chronic Liver Disease

NCT075888541 location

LIVERAGE™: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Moderate or Advanced Liver Fibrosis

NCT06632444525 locations

Pelvic Floor Muscle Training and Dynamic Neuromuscular Stabilization Exercises in Pediatric Patients

NCT072673642 locations

The Phase 1, Open-label, PET Trial Designed to Investigate the Effect of AZD2389 on FAP Occupancy in the Liver in Participants With Advanced Liver Fibrosis.

NCT070697252 locations

Single-cell Multiomics and Spatiotemporal Omics Analyze the Mechanism of Liver Degenerative Disease

NCT072655441 location