Isolated biliary atresia

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ORPHA:30391OMIM:210500Q44.2
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16Active trials48Specialists8Treatment centers

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UniteRare data is sourced from FDA.gov, ClinicalTrials.gov, Orphanet, OMIM, and NORD.
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Overview

Isolated biliary atresia (also called extrahepatic biliary atresia or BA) is a rare liver disease that affects newborns. In this condition, the bile ducts — the small tubes that carry bile from the liver to the intestine — are blocked or missing. Bile is a fluid the liver makes to help digest fats and remove waste. When bile cannot flow out of the liver, it builds up and causes serious damage to liver tissue over time. This damage is called cholestasis and can lead to liver scarring (cirrhosis) if not treated quickly. The most noticeable early signs are yellowing of the skin and eyes (jaundice) that does not go away after the first two weeks of life, pale or chalky-white stools, and dark yellow urine. Babies may also have a swollen belly and poor weight gain. These signs can look similar to normal newborn jaundice at first, which is why early testing is so important. Biliary atresia is the most common reason children need a liver transplant. The main treatment is a surgery called the Kasai procedure (hepatoportoenterostomy), which tries to restore bile flow. If done early — ideally before 60 days of age — it can slow liver damage significantly. Many children eventually need a liver transplant. With timely surgery and transplant when needed, many children can live into adulthood.

Also known as:

Key symptoms:

Yellowing of the skin and whites of the eyes (jaundice) lasting beyond 2 weeks of agePale, chalky, or clay-colored stoolsDark yellow or brown urineSwollen or enlarged bellyPoor weight gain or failure to thriveEnlarged liver (hepatomegaly)Enlarged spleen (splenomegaly)Itchy skinFatigue and low energyEasy bruising or bleedingFluid buildup in the belly (ascites) in advanced casesDelayed growth and development

Clinical phenotype terms (28)— hover any for plain English
Severe failure to thriveHP:0001525Fat malabsorptionHP:0002630Conjugated hyperbilirubinemiaHP:0002908Atretic gallbladderHP:0011984Acholic stoolsHP:0011985Elevated gamma-glutamyltransferase levelHP:0030948Dark yellow urineHP:0040321
Inheritance

Sporadic

Usually appears on its own, not inherited from a parent

Age of Onset

Neonatal

Begins at or shortly after birth (first 4 weeks)

Orphanet ↗OMIM ↗NORD ↗

FDA & Trial Timeline

10 events
Oct 2026Tolerability of Enteral NAC in Infants

Sanjiv Harpavat — PHASE1

TrialNOT YET RECRUITING
Jan 2026The Use of Near-Infrared Fluorescence Cholangiography With Indocyanine Green (ICG) in the Work Up of Neonatal Cholestasis

University of Alabama at Birmingham — EARLY_PHASE1

TrialRECRUITING
Oct 2025Cholangitis Definition and Treatment After Kasai Hepatoportoenterostomy for Biliary Atresia: TRACK-BA Study (TRacking Cholangitis Post Kasai in Biliary Atresia)

University Hospital, Geneva

TrialNOT YET RECRUITING
Sep 2025Stool Card in Biliary Atresia

Assiut University

TrialNOT YET RECRUITING
Jun 2025Clinical Outcomes of Early Kasai Surgery With Umbilical Cord MSCs in Biliary Atresia

Universitas Diponegoro — PHASE1

TrialNOT YET RECRUITING
Feb 2025Nutritional Intervention for Biliary Atresia

Tongji Hospital — NA

TrialRECRUITING
Jun 2024Efficacy of New Post Kasai ILBS Protocol in Biliary Atresia.

Institute of Liver and Biliary Sciences, India

TrialRECRUITING
Jun 2024Stem Cell Applications in Biliary Atresia Patients

Necmi Kadıoğlu Hospital — NA

TrialRECRUITING
May 2024Biliary Atresia Research Network Northeast

Yale University

TrialRECRUITING
Oct 2023Preoperative Serum FGF19 in the Prognosis of Biliary Atresia

Children's Hospital of Fudan University

TrialRECRUITING

Data sourced from FDA regulatory filings and ClinicalTrials.gov. Updated periodically.

Treatments

No FDA-approved treatments are currently listed for Isolated biliary atresia.

16 clinical trialsare actively recruiting — trials can provide access to cutting-edge therapies.

View clinical trials →

Clinical Trials

16 recruitingView all trials with filters →
Phase 32 trials
Efficacy and Safety of Odevixibat in Children With Biliary Atresia Who Have Undergone a Kasai HPE (BOLD)
Phase 3
Active
PI: Ipsen Medical Director (Ipsen) · Sites: Los Angeles, California; Palo Alto, California +70 more
An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of Odevixibat in Children With Biliary Atresia
Phase 3
Enrolling by Invitation
· Sites: Aurora, Colorado; Atlanta, Georgia +28 more
Phase 11 trial
Treating Primary Sclerosing Cholangitis and Biliary Atresia With Vancomycin
Phase 1
Actively Recruiting
PI: Yinka Davies, M.D. (Sacramento Pediatric Gastroenterology) · Sites: Sacramento, California · Age: 040 yrs
N/A4 trials
Molecular Characterization for Understanding Biliary Atresia
N/A
Actively Recruiting
· Sites: Paris, De; Paris
Stem Cell Applications in Biliary Atresia Patients
N/A
Actively Recruiting
PI: Mustafa Azizoglu, MD, PhD (Esenyurt State Hospital) · Sites: Istanbul, Istanbul · Age: 018 yrs
Preventive Effect of Prophylactic Oral Antibiotics Against Cholangitis After Kasai Portoenterostomy
N/A
Actively Recruiting
· Sites: Shanghai, Shanghai Municipality
Nutritional Intervention for Biliary Atresia
N/A
Actively Recruiting
· Sites: Wuhan, Hubei
Other8 trials
Efficacy of New Post Kasai ILBS Protocol in Biliary Atresia.
Actively Recruiting
· Sites: New Delhi, National Capital Territory of Delhi
Mapping Disease Pathways for Biliary Atresia
Actively Recruiting
· Sites: Pittsburgh, Pennsylvania
Biliary Atresia Research Network Northeast
Actively Recruiting
PI: Robert Cowles, MD (Yale University) · Sites: Hartford, Connecticut; New Haven, Connecticut +12 more · Age: 012 yrs
High Medium-chain Triglyceride Nutritional Support in Infants With Biliary Atresia
Actively Recruiting
PI: Tian Qian, M.D. PhD (Children's Hospital of Fudan University) · Sites: Shanghai, Shanghai Municipality
A Prospective Database of Infants With Cholestasis
Actively Recruiting
PI: Saul Karpen, MD, PhD (VCU School of Medicine) · Sites: Los Angeles, California; San Francisco, California +14 more
BILACO Trial: Biliary Atresia - a Severe Complex Congenital Liver Disease
Actively Recruiting
PI: Vibeke Brix Christensen, MD, PhD, DMSc (Rigshospitalet, Denmark) · Sites: Copenhagen · Age: 018 yrs
Preoperative Serum FGF19 in the Prognosis of Biliary Atresia
Actively Recruiting
· Sites: Shanghai, Shanghai Municipality
Biliary Atresia Study in Infants and Children
Actively Recruiting
PI: Sanjiv Harpavat, MD (Texas Children's/Baylor College of Medicine) · Sites: Los Angeles, California; San Francisco, California +14 more · Age: 020 yrs

Specialists

Showing 25 of 48View all specialists →
SP
Sanjiv Harpavat, MD. PhD
HOUSTON, TX
Specialist
PI on 1 active trial
RM
Robert Cowles, MD
NEW YORK, NY
Specialist
PI on 1 active trial
EM
Evan P Nadler, MD
FARMINGTON, CT
Specialist
PI on 1 active trial
MP
Mustafa Azizoglu, MD, PhD
Specialist
PI on 1 active trial
TP
Tian Qian, M.D. PhD
Specialist
PI on 1 active trial
VD
Vibeke Brix Christensen, MD, PhD, DMSc
Specialist
PI on 1 active trial
JM
Jonathan Dillman, MD
CINCINNATI, OH
Specialist
PI on 1 active trial
MP
Mei-Hwei Chang, Professor
Specialist
PI on 1 active trial1 Isolated biliary atresia publication
CO
Carsten R Engelmann, MD, OhD
Specialist
PI on 1 active trial
MN
Mark Nomden
Specialist
2 Isolated biliary atresia publications
JH
Jan B F Hulscher
Specialist
2 Isolated biliary atresia publications
LB
Lawrence C Brody
Specialist
1 Isolated biliary atresia publication
SC
Suzan L Carmichael
UPLAND, CA
Specialist
1 Isolated biliary atresia publication
MB
Michael J Bamshad
SEATTLE, WA
Specialist
1 Isolated biliary atresia publication
EB
Elizabeth E Blue
HAMPTON, NH
Specialist
1 Isolated biliary atresia publication
WN
Wendy N Nembhard
Specialist
1 Isolated biliary atresia publication
AS
Aniko Sabo
Specialist
1 Isolated biliary atresia publication
PS
Pagna Sok
Specialist
1 Isolated biliary atresia publication
JC
Jessica X Chong
Specialist
1 Isolated biliary atresia publication
JB
Janneke L M Bruggink
Specialist
2 Isolated biliary atresia publications
AB
Austin L Brown
Specialist
1 Isolated biliary atresia publication
EM
Ed Doo, MD
SAN FRANCISCO, CA
Specialist
PI on 3 active trials
AM
Averell Sherker, MD
WASHINGTON, DC
Specialist
PI on 2 active trials1 Isolated biliary atresia publication
MJ
Mary M Jenkins
Specialist
1 Isolated biliary atresia publication
MB
Marilyn L Browne
WICHITA, KS
Specialist
1 Isolated biliary atresia publication

Treatment Centers

8 centers
🏥 NORD

Baylor College of Medicine Rare Disease Center

Baylor College of Medicine

📍 Houston, TX

🏥 NORD

Stanford Medicine Rare Disease Center

Stanford Medicine

📍 Stanford, CA

🔬 UDN

NIH Clinical Center Undiagnosed Diseases Program

National Institutes of Health

📍 Bethesda, MD

🔬 UDN

UCLA UDN Clinical Site

UCLA Health

📍 Los Angeles, CA

🔬 UDN

Baylor College of Medicine UDN Clinical Site

Baylor College of Medicine

📍 Houston, TX

🔬 UDN

Harvard/MGH UDN Clinical Site

Massachusetts General Hospital

📍 Boston, MA

🏥 NORD

Mayo Clinic Center for Individualized Medicine

Mayo Clinic

📍 Rochester, MN

👤 Mayo Clinic Center for Individualized Medicine

🏥 NORD

UCLA Rare Disease Day Program

UCLA Health

📍 Los Angeles, CA

Travel Grants

No travel grants are currently matched to Isolated biliary atresia.

Search all travel grants →NORD Financial Assistance ↗

Community

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Latest news about Isolated biliary atresia

Disease timeline:

New recruiting trial: Nutritional Intervention for Biliary Atresia

A new clinical trial is recruiting patients for Isolated biliary atresia

New recruiting trial: Molecular Characterization for Understanding Biliary Atresia

A new clinical trial is recruiting patients for Isolated biliary atresia

New recruiting trial: High Medium-chain Triglyceride Nutritional Support in Infants With Biliary Atresia

A new clinical trial is recruiting patients for Isolated biliary atresia

New recruiting trial: Preoperative Serum FGF19 in the Prognosis of Biliary Atresia

A new clinical trial is recruiting patients for Isolated biliary atresia

New recruiting trial: Stem Cell Applications in Biliary Atresia Patients

A new clinical trial is recruiting patients for Isolated biliary atresia

New recruiting trial: Treating Primary Sclerosing Cholangitis and Biliary Atresia With Vancomycin

A new clinical trial is recruiting patients for Isolated biliary atresia

New recruiting trial: Biliary Atresia Research Network Northeast

A new clinical trial is recruiting patients for Isolated biliary atresia

New recruiting trial: The Use of Near-Infrared Fluorescence Cholangiography With Indocyanine Green (ICG) in the Work Up of Neonatal Cholestasis

A new clinical trial is recruiting patients for Isolated biliary atresia

New recruiting trial: BILACO Trial: Biliary Atresia - a Severe Complex Congenital Liver Disease

A new clinical trial is recruiting patients for Isolated biliary atresia

New recruiting trial: A Prospective Database of Infants With Cholestasis

A new clinical trial is recruiting patients for Isolated biliary atresia

Caregiver Resources

NORD Caregiver Resources

Support, advocacy, and financial assistance for caregivers of rare disease patients.

Mental Health Support

Rare disease caregiving can be isolating. Connect with counseling and peer support.

Family & Caregiver Grants

Financial assistance programs specifically for caregivers of rare disease patients.

Social Security Disability

Learn how rare disease patients may qualify for SSDI/SSI benefits.

Questions for your doctor

Bring these to your next appointment

  • Q1.How quickly does my baby need the Kasai procedure, and what happens if it is delayed?,What are the signs that the Kasai procedure is working, and how will we monitor liver function afterward?,At what point would you recommend a liver transplant, and how do we get on the transplant waiting list?,What vitamins and nutritional supplements does my child need, and for how long?,What infections should I watch for, and when should I go to the emergency room?,Are there any clinical trials or new treatments available for biliary atresia?,What support services — such as social work, nutrition counseling, or mental health support — are available for our family?

Common questions about Isolated biliary atresia

What is Isolated biliary atresia?

Isolated biliary atresia (also called extrahepatic biliary atresia or BA) is a rare liver disease that affects newborns. In this condition, the bile ducts — the small tubes that carry bile from the liver to the intestine — are blocked or missing. Bile is a fluid the liver makes to help digest fats and remove waste. When bile cannot flow out of the liver, it builds up and causes serious damage to liver tissue over time. This damage is called cholestasis and can lead to liver scarring (cirrhosis) if not treated quickly. The most noticeable early signs are yellowing of the skin and eyes (jaundic

How is Isolated biliary atresia inherited?

Isolated biliary atresia follows a sporadic inheritance pattern. Genetic counseling can help families understand recurrence risk and testing options.

At what age does Isolated biliary atresia typically begin?

Typical onset of Isolated biliary atresia is neonatal. Age of onset can vary across affected individuals.

Are there clinical trials for Isolated biliary atresia?

Yes — 16 recruiting clinical trials are currently listed for Isolated biliary atresia on UniteRare. See the clinical trials section on this page for phase, sponsor, and site details sourced from ClinicalTrials.gov.

Which specialists treat Isolated biliary atresia?

25 specialists and care centers treating Isolated biliary atresia are listed on UniteRare, sourced from ClinicalTrials.gov principal investigators, published research, and the NPPES NPI registry.