Recruiting

Biliary Atresia

Sponsor:

Arbor Research Collaborative for Health

Code:

NCT00345553

Conditions

Biliary Atresia

Eligibility Criteria

Sex: All

Age: 0 - 20

Healthy Volunteers: Not accepted

Study Details

Brief summary:

Little is known about the factors that cause biliary atresia nor the factors that influence disease progression. The purpose of this study is to collect the pertinent clinical information, genetic material and body fluid samples to enable investigators to address the following aims: To identify the gene or genes implicated in the etiology of BA; To characterize the natural history of the older, non-transplanted child with BA.

Conditions

Biliary Atresia

Study ID

NCT00345553

Start date

May 16, 2006

Status verified date

Jun, 2026

Completion date

May 31, 2029

Anticipated

Primary completion date

May 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 20

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Participants need to have a confirmed diagnosis of BA determined by chart review including review of pertinent diagnostic biopsy reports, radiologic reports and surgical reports (if surgery was performed).
2. Participants need to be >6 months of age up to and equal to the age of 20 (participants enrolled at 20 years of age will have one visit).
3. Participants with their native liver.
4. Parent, guardian or participant (if 18 years of age or older) is willing to provide informed consent and, when appropriate, the participant is willing to assent.

Exclusion Criteria:

1. Currently participating in the ChiLDReN study PROBE.
2. Inability to confirm original diagnostic evaluation of biliary atresia.
3. Inability or unwillingness of family or participant to participate in all scheduled visits.
4. History of liver transplantation.

Study Design

Enrollment

1265 participants

Anticipated

Interventions and Outcome Measures

Arms

1

Biliary atresia subjects who have their native liver

Primary outcome measure

  • To identify the gene or genes implicated in the etiology of BA [ Time Frame: Specimens for this aim are collected once during study, usually at baseline. ]

Central Contacts and Locations

Central contacts

Locations

Children's Hospital of Los Angeles

Recruiting

Los Angeles, California, United States, 90027

Contacts

Principal Investigator:

Rohit Kohli, MD

Children's Hospital Colorado

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Principal Investigator:

Ronald J Sokol, MD

Children's Healthcare of Atlanta - Emory University

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Principal Investigator:

Nitika Gupta, MD

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

Recruiting

Chicago, Illinois, United States, 60614

Contacts

Principal Investigator:

Estella Alonso, MD

Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

Principal Investigator:

Alexander Miethke, MD

Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Principal Investigator:

Kathleen Loomes, MD

Texas Children's Hospital (Baylor College of Medicine)

Recruiting

Houston, Texas, United States, 77030

Contacts

Principal Investigator:

Paula Hertel, MD

University of Utah

Recruiting

Salt Lake City, Utah, United States, 84113

Contacts

Principal Investigator:

Kyle Jensen, MD

Seattle Children's Hospital

Recruiting

Seattle, Washington, United States, 98105

Contacts

Principal Investigator:

Pamela Vaentino, MD

More Information

Sponsor

Arbor Research Collaborative for Health

Last update posted

Jun 4, 2026

Last verified

Jun, 2026

Keywords

  • Biliary Atresia
  • Cholestasis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Arbor Research Collaborative for Health on 2026-06-04.