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Could a blood test replace the biopsy needle after liver transplant?

NCT ID NCT01428700

Diagnosis Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 25, 2026 · Last updated Sep 25, 2026

Summary

After a liver transplant, doctors often struggle to tell whether rising liver enzymes mean the body is rejecting the new organ or whether hepatitis C is damaging it. The only way to check is a liver biopsy, an invasive procedure that can still leave the answer unclear. This study examines blood and liver tissue samples from liver transplant recipients to see whether specific patterns of gene activity can distinguish rejection from hepatitis C injury. If those patterns hold up, they could point toward a less invasive way to diagnose what is happening and guide treatment.

What this could mean

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

Active substance
gene expression testing of blood and liver tissue samples
What this could lead to
If the gene patterns prove reliable, doctors could one day check a blood sample instead of performing a liver biopsy to tell rejection from hepatitis C injury, and adjust immunosuppression sooner.
What could go wrong
This is a laboratory study of stored samples, not a treatment trial. The gene patterns may not prove accurate enough to replace biopsies, and the approach may not work for other transplant patients or other liver conditions.

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

275 people

The number who actually took part.

Start date

Aug 2011

Finished

Jan 2013

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

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

Who is studied

Patients enrolled in ITN030ST (NCT00135694)

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: * Specimens derived from subjects enrolled in the ITN030ST study. * Availability of adequate biopsy specimens with corresponding blood and/or serum collected within a 10 day window of a for-cause or protocol biopsy. Exclusion Criteria: * Withdrawal of consent for the ITN030ST study. * Absence of consent in the ITN030ST study for the collection and storage of samples of blood and tissue for future research studies.

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Conditions

The condition(s) this trial relates to.

acute transplant rejection hepatitis C virus infection

As listed by the trial registrant

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

Liver transplantation

More trials for these conditions

Other studies related to the condition(s) this trial covers.