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RecruitingNCT03273049BAUpdated Aug 10, 2026

Mapping Disease Pathways for Biliary Atresia

An observational study in Biliary Atresia, sponsored by University of Pittsburgh. Recruiting at 1 site in United States. Per ClinicalTrials.gov, last updated 2026-08-10.

Sponsored by University of Pittsburgh · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
1,100
Sex
All
01

Study summary

This project will primarily evaluate the developmental/genetic basis of biliary atresia, the most common cause of liver failure at birth, and which accounts of half of all liver transplants performed worldwide in children.

Read the detailed description

Characterized by failure to drain bile from the liver due to atretic extrahepatic bile ducts, BA is corrected in less than half of all affected children with surgical reconstruction. The remainder progress to cirrhosis and require liver transplantation. Because bile duct loss can be accompanied by other birth defects such as laterality defects of the gut and cardiovascular systems, the disease has been categorized into the more common 'isolated' variety presumably due to a perinatal viral cholangitis, and the 'syndromic' variety, due to genetic factors. Mechanistic differences implied by this categorization have not been demonstrated conclusively. In contrast, three susceptibility genes identified in predominantly 'isolated" BA cases, and the presence of abnormal cilia which are known to predispose to laterality defects, in both isolated and syndromic forms of BA suggest that in addition to environmental influences, genetic susceptibility is important in both forms of BA. This view is reinforced by our preliminary work which shows that knockdown of a novel BA susceptibility gene causes both biliary dysgenesis and laterality defects in animal models. This finding also suggests that common birth defects affecting the liver and other organs may originate from defects in the same genes. The project will combine candidate gene identification and replication with human DNA samples from 1100 BA subjects and their biological parents or siblings, if available, with validation using corresponding human BA liver tissue and zebrafish knockdown models.

The project outcome will consist of pathways comprising multiple susceptibility genes involved in morphogenesis of the liver and other organs, which explain the complex phenotype of BA. The project will use the experimental and bioinformatics capabilities of the Universities of Pittsburgh and California (at San Diego) to analyze data and study human samples from the participating centers. Four of the world's largest pediatric liver transplant centers, the Children's Hospitals of Pittsburgh (CHP), King's College Hospital (KCH), London, UK, Birmingham Children's Hospital, UK (BCH), and the Hospital Sirio Libanes (HSL), Sao Paulo, Brazil will enroll biliary atresia subjects and their biological parents and/or siblings, if available.

Information developed in this project will be the basis for designing novel management strategies to reduce the societal impact of this rare childhood disease.

02

Conditions studied

  • Biliary Atresia

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03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Individuals who have had a liver transplantation due to a diagnosis of biliary atresia.

Inclusion criteria

  • living individuals who were diagnosed with Biliary Atresia and received or are about to receive a liver transplant from multiple participating centers (Children's Hospital of Pittsburgh, Kings College Hospital, Children's Hospital of Birmingham, and Hospital Sírio-Libanês).

Exclusion criteria

Exclusion Criteria:

  • No child participant in the care of the state will be enrolled, nor will patients in the care of temporary or informal guardians be enrolled
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Study design

Observational model
Other
Time perspective
Prospective
Enrollment
1,100 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna
05

What researchers measure

Primary outcomes

  1. Genomic pathways of BA

    Main project outcome will consist of pathways comprising multiple susceptibility genes involved in morphogenesis of the liver and other organs, which explain the complex phenotype of BA.

    Time frame: up to two years

Secondary outcomes

  1. Predisposition of BA

    determine whether candidate genes and related pathways which predispose to BA, also predispose to laterality defects affecting the liver and other organs.

    Time frame: upwards of four years to achieve this outcome measure

06

Study locations

1 of 1 sites recruiting
  • UPMC Children's Hospital of Pittsburgh
    Pittsburgh, Pennsylvania 15224, United States
    Recruiting
07

Registry details

Key details

Study ID
NCT03273049
Lead sponsor
University of Pittsburgh
Collaborators
National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Responsible party
Rakesh Sindhi (Rakesh Sindhi, MD, Professor of Surgery, University of Pittsburgh) — Principal investigator
First posted
Sep 6, 2017
Start date
Jul 21, 2016
Primary completion
Dec 21, 2030 (estimated)
Completion
Jul 21, 2035 (estimated)
Last update
Aug 10, 2026

Study contacts

Morgan L Paul, BSN
Contact
Morgan.Paul2@upmc.edu
4126928472
Daniel Pieratt, MPA
Contact
pierattdw@upmc.edu
4126926692

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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