TruGraf Liver Gene Expression Serial Test

NCT06061341 | Enrolling By Invitation

• 1 other identifier: 202307175
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• Graft survival

  Organ recipients require long-term immunosuppression therapy along with frequent surveillance of the transplanted graft for indications of rejection, injury or failure.

  12 months

• Biopsy-Proven Acute Rejection (BPAR) results

  Will be assessed via biopsy

  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.

  12 months

• Clinical treatment of rejection

  Possible revision to immunosuppressive (IS) medications

  12 months

Secondary Outcomes (5)

• Number of changes to immunosuppressive (IS) agents

  12 months

• Number of IS medications

  12 months

• Immunosuppression reduction

  12 months

• Estimated Glomerular filtration rate (eGFR)

  12 months

• Immune mediated issues

  12 months

Study Arms (2)

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.

Diagnostic Test: TruGraf®

Matched historical control group

Group who will have immunosupression (IS) assessed utilizing traditional clinical parameters for IS management.

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.

TruGraf

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Transplant Genomics, Inc.: collaborator

Study Sites (2)

Washington University and Barnes Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Hepatitis, Autoimmune; Cholangitis, Sclerosing; Liver Cirrhosis, Biliary

Condition Hierarchy (Ancestors)

Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Autoimmune Diseases; Immune System Diseases; Cholangitis; Bile Duct Diseases; Biliary Tract Diseases; Cholestasis, Intrahepatic; Cholestasis; Liver Cirrhosis; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jason Wellen, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2023
• First Posted: September 29, 2023
• Study Start: August 1, 2024
• Primary Completion: November 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 26, 2025

Record last verified: 2025-08

Locations

US (2)