Liver TransplantationNCT07735650
Immunosuppressant Withdrawal Based on Parenchymal Chimerism in the Liver Transplantation
A study testing liver biopsy, Immunosuppression withdrawal and Immunosuppression minimization in people with Liver Transplantation and Liver Transplantation in Long-term, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Liver Transplantation, Liver Transplantation in Long-term
- What is being tested?
- liver biopsy, Immunosuppression withdrawal and Immunosuppression minimization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2025to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- a. The patients had liver transplantation, either deceased liver or liver donor, for ≥ 5 years.
- 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.
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Investigation of Transplant Tolerance and Immunosuppressant Withdrawal Based on Parenchymal Chimerism in the Liver
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.
Read the detailed description
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:
- To determine whether the liver allografts become chimeric in long-term liver transplant recipients.
- To determine the degree of liver chimerism in long-term liver transplant recipients.
- To determine whether immunosuppression can be withdrawn based on liver chimerism.
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.
- Being tested
- liver biopsy, Immunosuppression withdrawal, Immunosuppression minimization
- Keywords
- liver transplantation, chimerism, immunosuppression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liver biopsyProcedure or surgery
Liver tissue will be obtained to perform short tandem repeat (STR) analysis to determine the degree of parenchymal chimerism.
Immunosuppression withdrawalDrug
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.
Immunosuppression minimizationDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Procedure: liver biopsy; Drug: Immunosuppression withdrawal; Drug: Immunosuppression minimization |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (6)
Number of Participants with Successful Complete Immunosuppression Withdrawal
The number of enrolled patients who successfully complete the immunosuppression withdrawal protocol and remain immunosuppression-free without experiencing acute cell-mediated rejection.
Measured: up to 1 year
AST Levels
Aspartate aminotransferase (AST) levels will be monitored to evaluate liver allograft stability and function after immunosuppression withdrawal or minimization.
Measured: up to 1 year
ALT Levels
Alanine aminotransferase (ALT) levels will be monitored to evaluate liver allograft stability and function after immunosuppression withdrawal or minimization.
Measured: up to 1 year
eGFR (Estimated Glomerular Filtration Rate)
eGFR will be measured to evaluate the improvement of immunosuppressant-related renal adverse effects following drug withdrawal or minimization.
Measured: At 3 months after immunosuppression withdrawal
HbA1c (Glycated Hemoglobin)
HbA1c will be measured to evaluate the improvement of immunosuppressant-related metabolic adverse effects following drug withdrawal or minimization.
Measured: At 3 months after immunosuppression withdrawal
Cholesterol Profiles
Cholesterol profiles will be measured to evaluate the improvement of immunosuppressant-related metabolic adverse effects following drug withdrawal or minimization.
Measured: At 3 months after immunosuppression withdrawal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study start1 Aug 2025
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplantationStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- If the patients with \> 15% of chimerism of liver parenchyma, the immunosuppression will be taping, than withdrawn.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei-Chen Lee, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07735650
- Sponsor's protocol ID
- 202402038A3
- Status last verified
- Jul 2026
- First submitted
- 3 Dec 2025
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Investigation of Transplant Tolerance and Immunosuppressant Withdrawal Based on Parenchymal Chimerism in the Liver
- ClinicalTrials.gov ID
- NCT07735650
- Acronym / sponsor ID
- 202402038A3
- Keywords
- liver transplantation, chimerism, immunosuppression
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 30 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- To determine whether the liver allografts become chimeric in long-term liver transplant recipients.
- To determine the degree of liver chimerism in long-term liver transplant recipients.
- To determine whether immunosuppression can be withdrawn based on liver chimerism.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- If the patients with > 15% of chimerism of liver parenchyma, the immunosuppression will be taping, than withdrawn.
| Arm | Type | Receives |
|---|---|---|
| liver parenchyma chimerism in liver transplant recipient | Experimental | Procedure: liver biopsy, Drug: Immunosuppression withdrawal, Drug: Immunosuppression minimizationAll 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). |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- a. The patients had liver transplantation, either deceased liver or liver donor, for ≥ 5 years.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| liver biopsyLiver tissue will be obtained to perform short tandem repeat (STR) analysis to determine the degree of parenchymal chimerism. | Procedure or surgery | liver parenchyma chimerism in liver transplant recipient |
| Immunosuppression withdrawalFor 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. | Drug | liver parenchyma chimerism in liver transplant recipient |
| Immunosuppression minimizationFor 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. | Drug | liver parenchyma chimerism in liver transplant recipient |
Primary outcome
Percentage of Recipient Cells in the Liver Allograft
Time frame: 1 year
Short tandem repeat (STR) analysis is used to calculate the chimeric percentage of recipient cells in the liver parenchyma.
6 secondary outcomes
Number of Participants with Successful Complete Immunosuppression Withdrawal
Time frame: up to 1 year
AST Levels
Time frame: up to 1 year
ALT Levels
Time frame: up to 1 year
eGFR (Estimated Glomerular Filtration Rate)
Time frame: At 3 months after immunosuppression withdrawal
HbA1c (Glycated Hemoglobin)
Time frame: At 3 months after immunosuppression withdrawal
Cholesterol Profiles
Time frame: At 3 months after immunosuppression withdrawal
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing liver biopsy, Immunosuppression withdrawal and Immunosuppression minimization in people with Liver Transplantation and Liver Transplantation in Long-term, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Recipient Cells in the Liver Allograft (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026; AzTrials last refreshed its copy on 8 Nov 2026.