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New study aims to detect liver damage without needles

NCT ID NCT04612764

Knowledge-focused Sponsor: Baylor College 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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study looks at whether simple blood tests and special scans can detect liver scarring in people with urea cycle disorders. Researchers will enroll 62 participants across five U.S. centers. The goal is to find noninvasive ways to monitor liver health, avoiding the need for liver biopsies.

What this could mean

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

What this could lead to
If successful, this could lead to better, safer ways to monitor liver health in people with urea cycle disorders, reducing the need for invasive biopsies.
What could go wrong
This is an observational study, not testing a treatment. It may not find clear links between the tests and liver damage, 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 62 people

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

Started

Nov 2021

Expected to finish

Dec 2026

An estimate. End dates often move.

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

Individuals with urea cycle disorders

Ages

6 to 65 years

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.

Stage A Inclusion Criteria: * Age \> 6 years and \< 65 years * Weight ≥ 11 kg at time of screening * A molecular or biochemical diagnosis of OTCD, ASS1D, ASLD, or ARG1D. Exclusion Criteria: * Prior liver transplantation * Episode of acute hyperammonemia (≥100 umol/L) in the 30 days prior to enrollment * Confirmed diagnosis of chronic viral hepatitis, autoimmune liver disease, short gut, small bowel syndrome, alcohol liver disease, TPN requirement, or TPN-related cholestatic disease * Adults with BMI ≥ 45 kg/m2 * Current pregnancy * Open wound near expected Fibroscan® probe application site * Use of implantable active medical device such as cardiac pacemaker or implantable cardioverter-defibrillator Stage B Inclusion Criteria • Participation in Stage A of this study Exclusion Criteria * Individuals with claustrophobia or other inability to complete * Known diagnosis of hemochromatosis * Presence of implants or devices incompatible with MRI * Inability to breath-hold for 20 seconds for the elastography sequence * Current pregnancy * Confirmed diagnosis of chronic viral hepatitis, autoimmune liver disease, short gut, small bowel syndrome, alcohol liver disease, TPN requirement, or TPN-related cholestatic disease * Episode of documented acute hyperammonemia (ammonia ≥ 100 umol/L) in the 30 days prior to scheduled visit for Stage B

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Conditions

The condition(s) this trial relates to.

arginase deficiency argininosuccinic aciduria citrullinemia citrullinemia type I liver disorder ornithine carbamoyltransferase deficiency urea cycle disorder

As listed by the trial registrant

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

Argi deficiency Argininosuccinic aciduria Asl deficiency Ass deficiency Citrullinemia 1 Hyperargininemia Ornithine transcarbamylase deficiency Urea cycle disorder

Contacts and locations

Locations

  • Baylor College of Medicine

    Houston, Texas, 77030, United States

  • Children's Hospital Colorado

    Aurora, Colorado, 80045, United States

  • Children's National Medical Center

    Washington D.C., District of Columbia, 20010, United States

  • Seattle Children's Hospital

    Seattle, Washington, 98105, United States

  • The Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104, United States

More trials for these conditions

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