Autoimmune Liver DiseaseNCT06061341
TruGraf Liver Gene Expression Serial Test
An observational study of Autoimmune Liver Disease and Autoimmune Hepatitis, run by Washington University School of Medicine at 2 sites in United States.
Trial summary
This is an Investigator Initiated, single center, non-randomized, single arm study utilizing TruGraf liver gene expression serial testing in patients with autoimmune liver diseases (AIH, PSC, PBC) monthly for the first 6 months after transplant to help inform immunosuppression (IS) optimization. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autoimmune Liver Disease, Autoimmune Hepatitis, Primary Sclerosing Cholangitis
- What is being tested?
- TruGraf®
- How many people
- 13 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Aug 2024to 3 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Potential participants will be recruited from the patient population of the Washington University liver transplant surgeons. These patients are routinely evaluated pre- and post- transplant by transplant surgeons. Patients who are on the waitlist for liver transplantation will be screened to determine if they meet the study eligibility criteria. Screening may occur either pre-transplant or post-transplant.
Who may be able to join
- Recipients ≥18 years of age
- Currently waitlisted for liver transplant or recipient of liver transplant within the last 30 days
- Primary indication for transplant due to autoimmune hepatitis (AIH) - Primary Biliary Cirrhosis (PBC) or Primary Sclerosing Cholangitis (PSC) etiologies
- First time, single-organ liver transplant recipient
- Willing and able to undergo protocol required TruGraf serial blood draws
Who cannot join
- Recipient <18 years of age
- Recipients of multi-organ or repeat transplantation
- Grafts from donors with HIV
- Grafts from donors with viremic Hepatitis A, B, C
- Inability to meet study requirements
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Washington University and Barnes Jewish Hospital
St Louis, Missouri, 63110
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Usage of TruGraf Liver Gene Expression to Identify Subclinical Rejection as Well as Adjust Immunosuppression Medications in Liver Transplant Recipients Due to Autoimmune Disease
This is an Investigator Initiated, single center, non-randomized, single arm study utilizing TruGraf liver gene expression serial testing in patients with autoimmune liver diseases (AIH, PSC, PBC) monthly for the first 6 months after transplant to help inform immunosuppression (IS) optimization. Approximately 20 patients will be enrolled in the study. Study outcomes will include 1-year graft survival, 1 year BPAR and clinically treated rejection rates, number of changes to IS based on the results of Trugraf, eGFR and immune mediated issues.
TruGraf®, (Transplant Genomics, Inc., a member of Eurofins Transplant Diagnostics) is a non-invasive blood-based test to assist the clinician in lowering immunosuppression in liver transplant patients. It is the first and only blood-based test that offers biomarker guidance to aid physicians in minimizing immunosuppression in transplant recipients. Unfortunately, achieving the tight control of therapeutic levels of immunosuppression that is required to maintain the balance between "too much" and "too little" can be difficult. TruGraf liver can help clinicians confirm immune "quiescence" prior to, as well as following, immunosuppression reduction in patients with stable graft function, minimizing the risk of overt graft injury due to rejection.
The clinical context of use for TruGraf is to provide reassurance to the clinician who is contemplating a preemptive reduction in IS therapy that a patient's immune status is "quiescent" thus reducing the risk of triggering acute rejection with that IS reduction. Having the ability to assess whether the patient's immune status is "quiescent" or activated when considering an increase or decrease in IS therapy allows the clinician greater confidence in decision making.
Read the detailed description
Study Abstract Following liver transplantation, organ recipients require long-term immunosuppression therapy along with frequent surveillance of the transplanted graft for indications of rejection, injury or failure. Long-term death rates in liver transplantation are more often attributable to long-term intake of immunosuppression medications than to liver graft dysfunction. Excessive immunosuppression can lead to declining kidney function, recurrent infections and other issues especially in the aging recipient population while suboptimal immunosuppression can lead to allograft injury, rejection or failure.
Monitoring for graft health post-transplant typically relies upon measurements of immunosuppression drug levels, serum liver enzyme testing, clinical symptoms of graft rejection and invasive liver biopsies. The measurement of serum liver enzymes may not reflect the full story as these enzymes are insensitive for predicting immune response and are considered to be late indicators of organ injury and/or damage given that by the time the enzymes are elevated the liver damage may have already occurred.
Currently, the gold standard for the detection of subclinical (before definitive, observable symptoms) graft injury is an invasive liver biopsy. Many times liver grafts will have abnormal histological findings late after transplantation despite having normal liver enzymes. Also, interpretation may be difficult in the presence of infection or recurrence of primary disease. As discussed, standard liver enzyme blood tests are non-specific and have an insensitivity for detecting subclinical graft injury. There is a need for non-invasive biomarkers to predict the onset and severity of rejection and improvement in histological markers to make an accurate diagnosis.
The identification of non-invasive biomarkers for subclinical graft injury to help individualize immunosuppression therapy especially in patients with autoimmune liver diseases will allow for better management of allograft protection along with improved management of adverse side effects. In this study, non-invasive biomarker assessment will be performed, utilizing TruGraf liver gene expression testing, to serially monitor for early immune activation prior to acute rejection with the aim to inform immunosuppression therapy management in liver transplant recipients with autoimmune diseases of the liver.
Primary Hypothesis Can utilization of Trugraf Liver gene expression testing to alter immunosuppression (IS) protocols in liver transplant recipients with autoimmune disease reduce the need for post-transplant liver biopsy as well as 1-year graft rejection rates as compared to a matched historical control group?
- Conditions
- Autoimmune Liver Disease, Autoimmune Hepatitis, Primary Sclerosing Cholangitis, Primary Biliary Cirrhosis
- Being tested
- TruGraf®
- Medical subject headings
- Hepatitis, Autoimmune, Cholangitis, Sclerosing, Liver Cirrhosis, Biliary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TruGraf®Diagnostic test
TruGraf® is a non-invasive blood-based test to assist the clinician in lowering immunosuppression in liver transplant patients. It is the first and only blood-based test that offers biomarker guidance to aid physicians in minimizing immunosuppression in transplant recipients.
| Study group | Role | What they receive |
|---|---|---|
| TruGraf | Group who will have immunosuppression (IS) assessed utilizing TruGraf Liver Gene Expression test to serially monitor liver transplant recipients with autoimmune disease and alter IS based on these results. Receives: Diagnostic Test: TruGraf® | |
| Matched historical control group | Group who will have immunosupression (IS) assessed utilizing traditional clinical parameters for IS management. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Graft survival
Organ recipients require long-term immunosuppression therapy along with frequent surveillance of the transplanted graft for indications of rejection, injury or failure.
Measured: 12 months
Biopsy-Proven Acute Rejection (BPAR) results
Will be assessed via biopsy
Measured: 12 months
Confirmed rejection diagnosis
Based on clinical data including the patient's symptoms and signs and confirmed by laboratory studies of blood and a tissue biopsy.
Measured: 12 months
Clinical treatment of rejection
Possible revision to immunosuppressive (IS) medications
Measured: 12 months
Secondary outcomes (5)
Number of changes to immunosuppressive (IS) agents
Based on results of TruGraf liver gene expression test
Measured: 12 months
Number of IS medications
% of patients achieving monotherapy immunosuppression
Measured: 12 months
Immunosuppression reduction
% reduction from baseline
Measured: 12 months
Estimated Glomerular filtration rate (eGFR)
eGFR change from baseline to month 12
Measured: 12 months
Immune mediated issues
Infection incidence
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start1 Aug 2024
- Primary completion3 Dec 2025
- Study completion3 Dec 2025
Why it stopped: Funding discontinued
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Transplant Genomics, Inc.
- Responsible party
- Sponsor
- Investigators
- Jason Wellen, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06061341
- Sponsor's protocol ID
- 202307175
- Status last verified
- Aug 2026
- First submitted
- 20 Sep 2023
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usage of TruGraf Liver Gene Expression to Identify Subclinical Rejection as Well as Adjust Immunosuppression Medications in Liver Transplant Recipients Due to Autoimmune Disease
- ClinicalTrials.gov ID
- NCT06061341
- Acronym / sponsor ID
- 202307175
- Conditions
- Autoimmune Liver Disease, Autoimmune Hepatitis, Primary Sclerosing Cholangitis, Primary Biliary Cirrhosis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Funding discontinued
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Transplant Genomics, Inc.
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 3 Dec 2025 (actual)
- Study completion
- 3 Dec 2025 (actual)
- First posted
- 29 Sep 2023 (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.
This is an Investigator Initiated, single center, non-randomized, single arm study utilizing TruGraf liver gene expression serial testing in patients with autoimmune liver diseases (AIH, PSC, PBC) monthly for the first 6 months after transplant to help inform immunosuppression (IS) optimization. Approximately 20 patients will be enrolled in the study. Study outcomes will include 1-year graft survival, 1 year BPAR and clinically treated rejection rates, number of changes to IS based on the results of Trugraf, eGFR and immune mediated issues.
TruGraf®, (Transplant Genomics, Inc., a member of Eurofins Transplant Diagnostics) is a non-invasive blood-based test to assist the clinician in lowering immunosuppression in liver transplant patients. It is the first and only blood-based test that offers biomarker guidance to aid physicians in minimizing immunosuppression in transplant recipients. Unfortunately, achieving the tight control of therapeutic levels of immunosuppression that is required to maintain the balance between "too much" and "too little" can be difficult. TruGraf liver can help clinicians confirm immune "quiescence" prior to, as well as following, immunosuppression reduction in patients with stable graft function, minimizing the risk of overt graft injury due to rejection.
The clinical context of use for TruGraf is to provide reassurance to the clinician who is contemplating a preemptive reduction in IS therapy that a patient's immune status is "quiescent" thus reducing the risk of triggering acute rejection with that IS reduction. Having the ability to assess whether the patient's immune status is "quiescent" or activated when considering an increase or decrease in IS therapy allows the clinician greater confidence in decision making.
Detailed description
Study Abstract Following liver transplantation, organ recipients require long-term immunosuppression therapy along with frequent surveillance of the transplanted graft for indications of rejection, injury or failure. Long-term death rates in liver transplantation are more often attributable to long-term intake of immunosuppression medications than to liver graft dysfunction. Excessive immunosuppression can lead to declining kidney function, recurrent infections and other issues especially in the aging recipient population while suboptimal immunosuppression can lead to allograft injury, rejection or failure.
Monitoring for graft health post-transplant typically relies upon measurements of immunosuppression drug levels, serum liver enzyme testing, clinical symptoms of graft rejection and invasive liver biopsies. The measurement of serum liver enzymes may not reflect the full story as these enzymes are insensitive for predicting immune response and are considered to be late indicators of organ injury and/or damage given that by the time the enzymes are elevated the liver damage may have already occurred.
Currently, the gold standard for the detection of subclinical (before definitive, observable symptoms) graft injury is an invasive liver biopsy. Many times liver grafts will have abnormal histological findings late after transplantation despite having normal liver enzymes. Also, interpretation may be difficult in the presence of infection or recurrence of primary disease. As discussed, standard liver enzyme blood tests are non-specific and have an insensitivity for detecting subclinical graft injury. There is a need for non-invasive biomarkers to predict the onset and severity of rejection and improvement in histological markers to make an accurate diagnosis.
The identification of non-invasive biomarkers for subclinical graft injury to help individualize immunosuppression therapy especially in patients with autoimmune liver diseases will allow for better management of allograft protection along with improved management of adverse side effects. In this study, non-invasive biomarker assessment will be performed, utilizing TruGraf liver gene expression testing, to serially monitor for early immune activation prior to acute rejection with the aim to inform immunosuppression therapy management in liver transplant recipients with autoimmune diseases of the liver.
Primary Hypothesis Can utilization of Trugraf Liver gene expression testing to alter immunosuppression (IS) protocols in liver transplant recipients with autoimmune disease reduce the need for post-transplant liver biopsy as well as 1-year graft rejection rates as compared to a matched historical control group?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TruGraf | – | Diagnostic Test: TruGraf®Group who will have immunosuppression (IS) assessed utilizing TruGraf Liver Gene Expression test to serially monitor liver transplant recipients with autoimmune disease and alter IS based on these results. |
| Matched historical control group | – | –Group who will have immunosupression (IS) assessed utilizing traditional clinical parameters for IS management. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Potential participants will be recruited from the patient population of the Washington University liver transplant surgeons. These patients are routinely evaluated pre- and post- transplant by transplant surgeons. Patients who are on the waitlist for liver transplantation will be screened to determine if they meet the study eligibility criteria. Screening may occur either pre-transplant or post-transplant.
Key inclusion criteria (5 listed)
- Recipients ≥18 years of age
- Currently waitlisted for liver transplant or recipient of liver transplant within the last 30 days
- Primary indication for transplant due to autoimmune hepatitis (AIH) - Primary Biliary Cirrhosis (PBC) or Primary Sclerosing Cholangitis (PSC) etiologies
- First time, single-organ liver transplant recipient
- Willing and able to undergo protocol required TruGraf serial blood draws
Key exclusion criteria (5 listed)
- Recipient <18 years of age
- Recipients of multi-organ or repeat transplantation
- Grafts from donors with HIV
- Grafts from donors with viremic Hepatitis A, B, C
- Inability to meet study requirements
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 |
|---|---|---|
| TruGraf®TruGraf® is a non-invasive blood-based test to assist the clinician in lowering immunosuppression in liver transplant patients. It is the first and only blood-based test that offers biomarker guidance to aid physicians in minimizing immunosuppression in transplant recipients. | Diagnostic test | TruGraf |
Primary outcome
Graft survival
Time frame: 12 months
Organ recipients require long-term immunosuppression therapy along with frequent surveillance of the transplanted graft for indications of rejection, injury or failure.
Biopsy-Proven Acute Rejection (BPAR) results
Time frame: 12 months
Will be assessed via biopsy
Confirmed rejection diagnosis
Time frame: 12 months
Based on clinical data including the patient's symptoms and signs and confirmed by laboratory studies of blood and a tissue biopsy.
Clinical treatment of rejection
Time frame: 12 months
Possible revision to immunosuppressive (IS) medications
5 secondary outcomes
Number of changes to immunosuppressive (IS) agents
Time frame: 12 months
Number of IS medications
Time frame: 12 months
Immunosuppression reduction
Time frame: 12 months
Estimated Glomerular filtration rate (eGFR)
Time frame: 12 months
Immune mediated issues
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Funding discontinued). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
Related trials for Autoimmune Liver Disease
RecruitingPhase 2
Belimumab in Autoimmune Hepatitis
Autoimmune Hepatitis
RecruitingPhase 3
A Trial of Inebilizumab in Participants With Autoimmune Hepatitis
Autoimmune Hepatitis, AIH
Not yet recruitingPhase 3
J-LINX: Japan LINerixibat eXtension Study
Pruritus
Enrolling by invitationObservational study
Comparative Autoantibody and Immunologic Cell Marker Study
Autoimmune Diseases, Lupus Erythematosus, Systemic
Not yet recruitingObservational study
Thyroid Disorders in Pediatric Autoimmune Hepatitis
Thyroid Disease, Autoimmune Hepatitis
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. This study is not recruiting at the moment.
Jason Wellen, MD principal investigator
Washington University School of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autoimmune Liver Disease and Autoimmune Hepatitis, run by Washington University School of Medicine at 2 sites in United States.
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 5 inclusion and 5 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: stopped early, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
The study was stopped early (reason given: Funding discontinued). Results are not available in the source record.
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?
Graft survival (time frame: 12 months). The study lists 4 primary outcomes in all. 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 7 Aug 2026.