NCT06061341Terminated
TruGraf Liver Gene Expression Serial Test
Usage of TruGraf Liver Gene Expression to Identify Subclinical Rejection as Well as Adjust Immunosuppression Medications in Liver Transplant Recipients Due to Autoimmune Disease
Source: ClinicalTrials.gov · Last updated 7 Aug 2026
Reason given: Funding discontinued
Brief summary (registry, in English)
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.
- Status (registry)
- Terminated
- Study type
- Observational
- Enrollment
- 13 (actual)
- First submitted
- 20 Sept 2023
- Start date
- 1 Aug 2024
- Primary completion date
- 3 Dec 2025
- Lead sponsor
- Washington University School of Medicine
- Diseases
- Primary biliary cholangitis
- NCT number
- NCT06061341
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Recipients of multi-organ or repeat transplantation
Other illness
- Grafts from donors with HIV
- Grafts from donors with viremic Hepatitis A, B, C
Age
- Recipient <18 years of age
Other
- Inability to meet study requirements
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Washington University and Barnes Jewish Hospital | St Louis | United States | Unknown status |
| Washington University School of Medicine | St Louis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.