Chang-Gung Memorial Hospital
Taoyuan, 333, Taiwan
NCT Number: NCT07735650
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.
Interested in participating?
Request Info20 year and older
All sexes
Interventional
Not applicable
Taoyuan, 333, Taiwan
After liver transplantation, immunosuppression should be induced or maintained to prevent acute cell-mediated rejection or chronic antibody-mediated rejection.All these immunosuppressive agents have various adverse effects including nephrotoxicity, neurotoxicity, hyperglycemia, hypertension, bone marrow suppression, gastrointestinal disturbance, etc. We examine the liver specimen from long-term liver transplant recipients with stable liver function. The liver showed chimeric change of the liver. Therefore, the hypothesis of this study is that immunosuppressive agents can be withdrawn if the liver becomes chimeric. The specific aims of this study are:
Based on the degree of chimeric change of the liver grafts, immunosuppression withdrawal can be conducted in this study and find out the indicator of immunosuppression withdrawal in liver transplantation setting.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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
Exclusion criteria
Liver tissue will be obtained to perform short tandem repeat (STR) analysis to determine the degree of parenchymal chimerism.
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 If liver function is unaltered, immunosuppression is totally withdrawn at the 3rd month.
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.
Time frame: 1 year
Short tandem repeat (STR) analysis is used to calculate the chimeric percentage of recipient cells in the liver parenchyma.
Time frame: up to 1 year
The number of enrolled patients who successfully complete the immunosuppression withdrawal protocol and remain immunosuppression-free without experiencing acute cell-mediated rejection.
Time frame: up to 1 year
Aspartate aminotransferase (AST) levels will be monitored to evaluate liver allograft stability and function after immunosuppression withdrawal or minimization.
Time frame: up to 1 year
Alanine aminotransferase (ALT) levels will be monitored to evaluate liver allograft stability and function after immunosuppression withdrawal or minimization.
Time frame: At 3 months after immunosuppression withdrawal
eGFR will be measured to evaluate the improvement of immunosuppressant-related renal adverse effects following drug withdrawal or minimization.
Time frame: At 3 months after immunosuppression withdrawal
HbA1c will be measured to evaluate the improvement of immunosuppressant-related metabolic adverse effects following drug withdrawal or minimization.
Time frame: At 3 months after immunosuppression withdrawal
Cholesterol profiles will be measured to evaluate the improvement of immunosuppressant-related metabolic adverse effects following drug withdrawal or minimization.
Chang Gung Memorial Hospital
Other
The Investigation of Transplant Tolerance and Immunosuppressant Withdrawal Based on Parenchymal Chimerism in the Liver
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07703735
Adenocarcinoma, Carcinoma
View Trial DetailsNCT07651748
Liver Transplantation
Rotterdam, South Holland, Netherlands
View Trial DetailsNCT07247877
Liver Transplantation
View Trial DetailsNCT07530913
Liver Transplantation
Seoul, South Korea
View Trial Details