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Blood test may tame the tightrope walk of transplant drugs

NCT ID NCT06061341

Diagnosis Sponsor: Washington University School of Medicine Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 07, 2026 · Last updated Aug 07, 2026

Summary

This study tests whether a blood test called TruGraf can help doctors fine-tune immunosuppression medications in liver transplant recipients with autoimmune liver diseases like autoimmune hepatitis, primary sclerosing cholangitis, or primary biliary cirrhosis. The test measures gene expression to indicate whether the immune system is quiet or active, potentially allowing doctors to reduce drug doses safely without triggering rejection. Participants will have monthly blood draws for the first six months after transplant, and researchers will track graft survival, rejection episodes, and kidney function.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
TruGraf® liver gene expression blood test
What this could lead to
If successful, this blood test could help doctors safely lower immunosuppression in liver transplant patients, reducing side effects while avoiding rejection.
What could go wrong
This is a small, early-stage study with only about 13 participants, so results may not apply broadly. The test's accuracy and benefit over standard care are not yet proven.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

13 people

The number who actually took part.

Started

Aug 2024

Finished

Dec 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Criteria: * 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

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Conditions

The condition(s) this trial relates to.

autoimmune hepatitis Cholangitis, Sclerosing primary biliary cholangitis primary sclerosing cholangitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Autoimmune hepatitis Autoimmune liver disease Primary biliary cirrhosis Primary sclerosing cholangitis

Contacts and locations

Locations

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

  • Washington University and Barnes Jewish Hospital

    St Louis, Missouri, 63110, United States

More trials for these conditions

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