TruGraf Liver Gene Expression Serial Test

Conditions

• Autoimmune Hepatitis
• Autoimmune Liver Disease
• Primary Biliary Cirrhosis
• Primary Sclerosing Cholangitis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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 Details

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.

Key Dates

Start date

Aug 1, 2024

Status verified

Aug 2025

Primary completion

Nov 30, 2025

Completion

Dec 31, 2026

Study Design

Enrollment

20 participants (estimated)

Arms

• Arm: 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.
• Arm: Matched historical control group
  Group who will have immunosupression (IS) assessed utilizing traditional clinical parameters for IS management.

Primary Outcome Measure

Graft survival [ Time Frame: 12 months ]

Locations (2)

Find similar trials in St Louis, MO

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