Immunosuppressant Withdrawal Based on Parenchymal Chimerism in the Liver Transplantation

NCT07735650 | Enrolling By Invitation DMC

• 1 other identifier: 202402038A3
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn whether liver parenchyma chimerism can represent a chievement of operational tolerance in liver transplantation recipients. The researchers will examine the degree of parenchyma chimerism. The participants will withdraw or minimize their immunosuppression to avoid the adverse effects of immunosuppressants.

Conditions

Liver Transplantation; Liver Transplantation in Long-term

Keywords

liver transplantation, chimerism, immunosuppression

Outcome Measures

Primary Outcomes (1)

• Percentage of Recipient Cells in the Liver Allograft

  Short tandem repeat (STR) analysis is used to calculate the chimeric percentage of recipient cells in the liver parenchyma.

  1 year

Secondary Outcomes (6)

• Number of Participants with Successful Complete Immunosuppression Withdrawal

  up to 1 year

• AST Levels

  up to 1 year

• ALT Levels

  up to 1 year

• eGFR (Estimated Glomerular Filtration Rate)

  At 3 months after immunosuppression withdrawal

• HbA1c (Glycated Hemoglobin)

  At 3 months after immunosuppression withdrawal

Study Arms (1)

liver parenchyma chimerism in liver transplant recipient

EXPERIMENTAL

All enrolled liver transplant recipients will undergo a liver biopsy for STR analysis. Based on the degree of chimerism found, patients will proceed to either an immunosuppression withdrawal protocol (if STR $\\ge$ 75% percentile cutoff) or an immunosuppression minimization protocol (if STR \> 15% but \< 75% percentile).

Procedure: liver biopsy; Drug: Immunosuppression withdrawal; Drug: Immunosuppression minimization

Interventions

liver biopsy PROCEDURE

Liver tissue will be obtained to perform short tandem repeat (STR) analysis to determine the degree of parenchymal chimerism.

liver parenchyma chimerism in liver transplant recipient

Immunosuppression withdrawal DRUG

For patients with an STR $\\ge$ 75% percentile cutoff, half dose of the immunosuppressive regimen is decreased for the first two months. If liver function is unaltered, immunosuppression is totally withdrawn at the 3rd month.

liver parenchyma chimerism in liver transplant recipient

Immunosuppression minimization DRUG

For patients with STR \> 15% but not reaching the 75% percentile cutoff, the immunosuppressive regimen is decreased by 1/3 at the first two months. If liver function is unaltered, it is further decreased to 1/2 of the original dose.

liver parenchyma chimerism in liver transplant recipient

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• a. The patients had liver transplantation, either deceased liver or liver donor, for ≥ 5 years.
• b. Age ≥ 20 years old. c. The patients have stable liver function, and do not have clinical suspicious of acute cell-mediated rejection within 1 year.
• d. Sign the informed consent. e. Platelet ≥ 80000/mm3. f. INR ≤ 1.4 g. AST and ALT ≤ 1.5X h. Albumin ≥ 3.5gm/dl. i. Total bilirubin \< 1.5mg/dl. j. ECOG ≤ 2

You may not qualify if:

• a. Liver transplantation less than 5 years b. Abnormal liver function AST and ALT \> 1.5X c. Severe infection d. De novo malignancy e. Disagree to have liver biopsy. f. ECOG \> 2

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang-Gung Memorial Hospital

Taoyuan, 333, Taiwan

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, liver transplantation program

Model Details: If the patients with \> 15% of chimerism of liver parenchyma, the immunosuppression will be taping, than withdrawn.

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: July 30, 2026
• Study Start: August 1, 2025
• Primary Completion: July 31, 2026
• Study Completion (Estimated): July 31, 2027
• Last Updated: July 30, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)