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NCT06061341

TruGraf Liver Gene Expression Serial Test

Enrolling by Invitation
Not specifiedAges 18+Observational
Washington University School of Medicine
~20 participants
Updated 2025-08-26 on ClinicalTrials.gov
What's tested:TruGraf®

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Graft survival
Measured over 12 months
+3 more outcomes measured

Conditions

Autoimmune Liver Disease
Autoimmune Hepatitis
Primary Sclerosing Cholangitis
Primary Biliary Cirrhosis

Explore related trials

Autoimmune HepatitisPrimary Biliary CirrhosisPrimary Sclerosing Cholangitis

Where it's being run

2 sites across 1 states
Missouri2

Study leadership

  • Jason Wellen, MD · PRINCIPAL_INVESTIGATOR · Washington University School of Medicine

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

  • Graft survival12 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) results12 months

    Will be assessed via biopsy

  • Confirmed rejection diagnosis12 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 rejection12 months

    Possible revision to immunosuppressive (IS) medications