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New database aims to unlock secrets of childhood liver disease

NCT ID NCT00061828

Knowledge-focused Sponsor: Arbor Research Collaborative for Health Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is creating a large database of information and samples from 1,000 infants with cholestasis, a condition that causes prolonged jaundice. The goal is to better understand diseases like biliary atresia and find ways to improve care. Researchers will track how the disease progresses over time.

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 research could lead to better understanding and treatments for childhood liver diseases.
What could go wrong
This is an observational study, not a treatment trial. It may not directly lead to new therapies, and results depend on long-term follow-up.

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 1,000 people

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

Started

Apr 2004

Expected to finish

May 2029

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

This study population will be selected from the patient base of participating specialty care clinics.

Ages

Up to 6 months

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 * Infant's age less than or equal to 180 days at initial presentation at the ChiLDReN clinical site. * Diagnosis of cholestasis defined by serum direct or conjugated bilirubin greater than or equal to 2 mg/dl and suspected biliary atresia. * The subject's parent(s)/guardian(s) willing to provide informed written consent. EXCLUSION CRITERIA * Acute liver failure. * Previous hepatobiliary surgery with dissection or excision of biliary tissue. * Diagnoses of bacterial or fungal sepsis (except where associated with metabolic liver disease) * Diagnoses of hypoxia, shock or ischemic hepatopathy within the past two weeks (If the cholestasis persists beyond two weeks of the initiating event, the infant can be enrolled). * Diagnosis of any malignancy. * Presence of any primary hemolytic disease (except when diagnosed with biliary atresia or another cholestatic disease being studied by ChiLDREN). * Diagnosis of any drug or Total parenteral nutrition (TPN)-associated cholestasis (except when diagnosed with biliary atresia or another cholestatic disease being studied by ChiLDREN). * Diagnosis with Extracorporeal membrane oxygenation (ECMO)-associated cholestasis. * Birth weight less than 1500g (except when diagnosed with biliary atresia).

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Conditions

The condition(s) this trial relates to.

biliary atresia

As listed by the trial registrant

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

Biliary atresia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    9 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Ann & Robert H. Lurie Children's Hospital of Chicago

    RECRUITING

    Chicago, Illinois, 60614, United States

  • Baylor College of Medicine

    RECRUITING

    Houston, Texas, 77030, United States

  • Children's Healthcare of Atlanta - Emory University

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Children's Hospital Colorado

    RECRUITING

    Aurora, Colorado, 80045, United States

  • Children's Hospital Los Angeles

    RECRUITING

    Los Angeles, California, 90027, United States

  • Children's Hospital of Philadelphia

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Cincinnati Children's Hospital Medical Center

    RECRUITING

    Cincinnati, Ohio, 45229, United States

  • Johns Hopkins School of Medicine

    COMPLETED

    Baltimore, Maryland, 21287, United States

  • Mount Sinai Medical Center

    COMPLETED

    New York, New York, 10029, United States

  • Riley Hospital for Children

    COMPLETED

    Indianapolis, Indiana, 46202, United States

  • Seattle Children's Hospital

    RECRUITING

    Seattle, Washington, 98105, United States

  • The Hospital for Sick Children

    COMPLETED

    Toronto, Ontario, M5G 1X8, Canada

  • UPMC Children's Hospital of Pittsburgh

    COMPLETED

    Pittsburgh, Pennsylvania, 15224, United States

  • University of California

    COMPLETED

    San Francisco, California, 94143, United States

  • University of Utah

    RECRUITING

    Salt Lake City, Utah, 84113, United States

  • Washington University School of Medicine

    COMPLETED

    St Louis, Missouri, 63110, United States

More trials for these conditions

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