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Blood test could transform liver transplant monitoring

NCT ID NCT04793360

Knowledge-focused Sponsor: CareDx 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 This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 2 times

Summary

This study is testing a new blood test called LiverCare to see if it can better monitor liver transplant recipients for complications like rejection. Researchers will follow 1,500 patients for up to a year, comparing the new test with standard monitoring. The goal is to improve early detection and outcomes without extra needle sticks.

What this could mean

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

Active substance
LiverCare blood test kit (device for blood collection and analysis)
What this could lead to
If successful, this could lead to a more accurate and less invasive way to monitor liver transplant patients, potentially catching problems like rejection earlier.
What could go wrong
This is an observational study, not a treatment trial. The test may not prove better than current monitoring methods, and results may not apply to all patients.

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

About 1,500 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2021

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Who is studied

All liver transplant patients without exclusion criteria will be eligible to enter the study. Patients will be approached by the study team at the time of transplant or within 60 days post-transplant to discuss the trial, consent and enrollment.

Ages

12 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: * Liver transplant recipients \<60 days post-transplant (de-novo or re-transplant). * Participant is willing and able to give informed consent for participation in the trial. * Male or Female, aged 12 years or above (Gillick Competent). * In the Investigator's opinion, is able and willing to comply with all trial requirements. Exclusion Criteria: * Female participant who is pregnant, lactating or planning pregnancy during the course of the trial. * Has evidence of significant post-transplant impairment of hepatic function which is unlikely to improve (determined by the PI). * Scheduled elective surgery or other procedures requiring general anaesthesia during the trial. * Participant with life expectancy of less than 6 months or is inappropriate for diagnostic monitoring through regular blood sampling. * Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial. * Participants who have participated in another research trial involving an investigational product in the past 12 weeks\*. * Multi-organ transplant recipients or dual organ transplant recipients. * Patients with significant needle phobia.

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As listed by the trial registrant

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

Biomarkers Liver transplantation

Contacts and locations

Locations

  • Atrium Health

    Charlotte, North Carolina, 28204, United States

  • Baylor College of Medicine

    Houston, Texas, 77030, United States

  • Beth Israel Deaconess Medical Center (BIDMC)

    Boston, Massachusetts, 02215, United States

  • Duke University

    Durham, North Carolina, 27710, United States

  • Henry Ford Health System

    Detroit, Michigan, 48202, United States

  • INTEGRIS Baptist Medical Center

    Oklahoma City, Oklahoma, 73112, United States

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

  • Intermountain Medical Center

    Murray, Utah, 84107, United States

  • Keck Medical Center of USC

    Los Angeles, California, 90033, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • MedStar Georgetown University Hospital

    Washington D.C., District of Columbia, 20007, United States

  • Medical Unversity of South Carolina

    Charleston, South Carolina, 29425, United States

  • Methodist Health System

    Dallas, Texas, 75203, United States

  • Piedmont Healthcare

    Atlanta, Georgia, 30309, United States

  • Tampa General Hospital

    Tampa, Florida, 33606, United States

  • Tulane University

    New Orleans, Louisiana, 70112, United States

  • University of Cincinnati

    Cincinnati, Ohio, 45267, United States

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160, United States

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • University of Nebraska Medical Center/ Nebraska Medicine

    Omaha, Nebraska, 68198, United States

  • University of Tennessee_Methodist Healthcare

    Memphis, Tennessee, 38104, United States

  • University of Washington

    Seattle, Washington, 98195, United States

  • Virginia Commonwealth University

    Richmond, Virginia, 23219, United States

  • Washington Unversity in St. Louis

    St Louis, Missouri, 63110, United States

  • Westchester Medical Center

    Valhalla, New York, 10595, United States

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