Biliary Atresia Study in Infants and Children
BASIC
19 other identifiers
observational
1,265
2 countries
16
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2006
Longer than P75 for all trials
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 16, 2006
CompletedFirst Submitted
Initial submission to the registry
June 27, 2006
CompletedFirst Posted
Study publicly available on registry
June 28, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2029
October 15, 2025
September 1, 2025
23.1 years
June 27, 2006
October 14, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To identify the gene or genes implicated in the etiology of BA
The genetics of BA may be investigated on two levels. The first is to identify a group of patients whose etiology is a result of a genetic defect and the second is to examine the influence of genetics on disease acquisition.
Specimens for this aim are collected once during study, usually at baseline.
Secondary Outcomes (1)
Define the natural history of the older, non-transplanted child with biliary atresia
Observational information collected at entrance into study as well as at each yearly follow-up visit.
Study Arms (1)
1
Biliary atresia subjects who have their native liver
Eligibility Criteria
Recruitment will be open to any eligible subject. The method of contacting the study subjects will conform to local IRB guidelines, but in general: the parents or guardians of all eligible subjects at each ChiLDReN center, or the subjects themselves if 18 years of age or older, will be approached to participate. New patients who are not participating in ChiLDReN study PROBE may be approached for study participation, but will not be eligible for enrollment until 6 months of age.
You may qualify if:
- 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).
- 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).
- Participants with their native liver.
- 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.
You may not qualify if:
- Currently participating in the ChiLDReN study PROBE.
- Inability to confirm original diagnostic evaluation of biliary atresia.
- Inability or unwillingness of family or participant to participate in all scheduled visits.
- History of liver transplantation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Children's Hospital of Los Angeles
Los Angeles, California, 90027, United States
University of California at San Francisco
San Francisco, California, 94143, United States
Children's Hospital Colorado
Aurora, Colorado, 80045, United States
Children's Healthcare of Atlanta - Emory University
Atlanta, Georgia, 30322, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60614, United States
Riley Children's Hospital
Indianapolis, Indiana, 46202, United States
Johns Hopkins School of Medicine
Baltimore, Maryland, 21287, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Mount Sinai Medical Center
New York, New York, 10029, United States
Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224, United States
Texas Children's Hospital (Baylor College of Medicine)
Houston, Texas, 77030, United States
University of Utah
Salt Lake City, Utah, 84113, United States
Seattle Children's Hospital
Seattle, Washington, 98105, United States
Hospital for Sick Children
Toronto, Ontario, M5G 1X8, Canada
Related Publications (1)
Ng VL, Haber BH, Magee JC, Miethke A, Murray KF, Michail S, Karpen SJ, Kerkar N, Molleston JP, Romero R, Rosenthal P, Schwarz KB, Shneider BL, Turmelle YP, Alonso EM, Sherker AH, Sokol RJ; Childhood Liver Disease Research and Education Network (CHiLDREN). Medical status of 219 children with biliary atresia surviving long-term with their native livers: results from a North American multicenter consortium. J Pediatr. 2014 Sep;165(3):539-546.e2. doi: 10.1016/j.jpeds.2014.05.038. Epub 2014 Jul 9.
PMID: 25015575DERIVED
Related Links
Biospecimen
Samples of blood will be collected for research purposes.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Sanjiv Harpavat, MD
Texas Children's/Baylor College of Medicine
- STUDY DIRECTOR
Ed Doo, MD
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- PRINCIPAL INVESTIGATOR
John C Magee, MD
University of Michigan
- PRINCIPAL INVESTIGATOR
Lisa Henn, PhD
Arbor Research Collaborative for Health - Data Coordinating Center
- STUDY DIRECTOR
Katrina Loh, MD
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 27, 2006
First Posted
June 28, 2006
Study Start
May 16, 2006
Primary Completion (Estimated)
May 31, 2029
Study Completion (Estimated)
May 31, 2029
Last Updated
October 15, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
The data will be transferred to NIDDK at the end of the study.