Clinical trials: Biliary Atresia
Rare Disorders, Undiagnosed Disorders
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
The Coordination of Rare Diseases at Sanford (CoRDS) is an international patient registry that serves as a centralized resource for rare disease research.
- Conditions
- Rare Disorders, Undiagnosed Disorders, Disorders of Unknown Prevalence, Cornelia De Lange Syndrome
- Trial name
- CoRDS (NCT01793168)
- Where
- United States
- Volunteers
- 20,000 people
- Sponsor
- Sanford Health
Biliary Atresia
An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of Odevixibat in Children With Biliary Atresia
An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of Odevixibat (A4250) in Children with Biliary Atresia
- Trial name
- BOLD-EXT (NCT05426733)
- Testing
- Odevixibat
- Where
- 30 sites in United States, Australia and 12 more
- Volunteers
- 180 people
- Sponsor
- Albireo, an Ipsen Company
Biliary Atresia
Molecular Characterization for Understanding Biliary Atresia
Although considered a rare disease, Biliary Atresia (BA) is the leading cause of neonatal cholestasis and liver transplantation in children. Little is known about the molecular mechanisms that drive BA.
- Trial name
- CAVB (NCT04272515)
- Testing
- blood sampling, skin biopsy sampling, explanted liver of BA patients sampling
- Where
- 2 sites in France
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Institut National de la Santé Et de la Recherche Médicale, France
Cholestatic Liver Disease (Except ALGS, PFIC, PBC and PSC)
Evaluation of Maralixibat in Pruritus Associated With General Cholestatic Liver Disease (EXPAND)
The purpose of this study is to determine whether the investigational treatment (maralixibat) is safe and effective in pediatric and adult participants who have cholestatic liver disease with pruritus that has been refractory to…
- Trial name
- NCT06553768
- Testing
- Maralixibat
- Where
- 23 sites in United States, Brazil and 8 more
- Volunteers
- 90 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Biliary Atresia
Safety Study of Intravenous Immunoglobulin (IVIG) Post-Portoenterostomy in Infants With Biliary Atresia
The Children Liver Disease Research and Education Network (ChiLDREN) is conducting a clinical trial to determine the feasibility, acceptability, tolerability and safety profile of IVIG treatment administered to infants after…
- Trial name
- PRIME (NCT01854827)
- Testing
- Intravenous immunoglobulin (IVIG)
- Where
- 7 sites in United States, Canada
- Volunteers
- 30 people
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Biliary Atresia, Kasai Operation
Umbilical Cord Mesenchymal Stem Cell Therapy for Biliary Atresia
Biliary atresia is a progressive liver disease in infants where liver transplantation is often the only long-term option once cirrhosis develops.
- Conditions
- Biliary Atresia, Kasai Operation, Liver Fibrosis, Stem Cell
- Trial name
- NCT07797673
- Testing
- Umbilical Cord-Mesenchymal Stem Cells (UC-MSC), Kasai Portoenterostomy
- Where
- Indonesia
- Volunteers
- 40 people
- Sponsor
- Dr Cipto Mangunkusumo General Hospital
Biliary Atresia
Mapping Disease Pathways for Biliary Atresia
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.
- Trial name
- BA (NCT03273049)
- Where
- United States
- Volunteers
- 1,100 people
- Sponsor
- University of Pittsburgh
Hepatobiliary Disease, Biliary Atresia
Dry Blood Spot Screening Test for Biliary Atresia（DBS-SCReBA）
Our study aims to develop a screening test for biliary atresia (BA) using dry blood spot to improve patient survival by early diagnosis.
- Conditions
- Hepatobiliary Disease, Biliary Atresia, Neonatal Cholestasis
- Trial name
- NCT03898765
- Testing
- Dry blood spot screening
- Where
- China
- Sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Choledochal Cyst Resection, Biliary Atresia, Kasai Portoenterostomy Status
ERAS in Choledochal Cyst & Biliary Atresia
This study aims to compare two feeding approaches after surgery for biliary atresia and choledochal cyst in children. Traditionally, children are kept without oral feeding for more than 48 hours after these operations until bowel…
- Trial name
- NCT07709702
- Testing
- Enhanced Recovery After Surgery, Post-operative care
- Where
- Pakistan
- Volunteers
- 100 people
- Sponsor
- Muhammad Zubair Shoukat
Cholestasis in Newborn, Biliary Atresia
The Dirty Nappy Study
This observational study evaluates whether a machine-learning algorithm, a computer program that learns patterns from data, can accurately diagnose cholestasis in newborns.
- Conditions
- Cholestasis in Newborn, Biliary Atresia, Neonatal Cholestasis
- Trial name
- NCT07697872
- Where
- United Kingdom
- Volunteers
- 5,350 people, healthy volunteers welcome
- Sponsor
- Birmingham Women's and Children's NHS Foundation Trust
Biliary Atresia
Study to Assess Efficacy, Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Obeticholic Acid (OCA) Compared to Placebo in Pediatric Participants With Biliary Atresia, Post-hepatoportoenterostomy
This study will evaluate the efficacy, safety and tolerability, as well as PK/PD of OCA in eligible pediatric participants with biliary atresia with successful hepatoportoenterostomy (HPE, also known as a Kasai portoenterostomy).
- Trial name
- NCT06121375
- Testing
- OCA
- Where
- 24 sites in Australia, Canada and 8 more
- Volunteers
- 28 people
- Sponsor
- Intercept Pharmaceuticals
Biliary Atresia
Efficacy and Safety of Odevixibat in Children With Biliary Atresia Who Have Undergone a Kasai HPE (BOLD)
Double-blind, randomized, placebo-controlled, Phase 3 study to investigate the efficacy and safety of odevixibat compared to placebo in children with biliary atresia who have undergone a Kasai hepatoportoenterostomy.
- Trial name
- NCT04336722
- Testing
- Odevixibat
- Where
- 72 sites in United States, Australia and 17 more
- Volunteers
- 254 people
- Sponsor
- Albireo, an Ipsen Company
Biliary Atresia
Biliary Atresia Research Network Northeast
This is a multi-center retrospective chart review to compile a data repository of the management and outcomes of children with biliary atresia.
- Trial name
- BARNN (NCT06184971)
- Where
- 14 sites in United States
- Volunteers
- 320 people
- Sponsor
- Yale University
Biliary Atresia
A Prospective Database of Infants With Cholestasis
Biliary atresia, idiopathic neonatal hepatitis, and specific genetic cholestatic conditions are the most common causes of jaundice and hyperbilirubinemia that continue beyond the newborn period.
- Trial name
- PROBE (NCT00061828)
- Where
- 16 sites in United States, Canada
- Volunteers
- 1,000 people
- Sponsor
- Arbor Research Collaborative for Health
Biliary Atresia
Biliary Atresia Study in Infants and Children
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…
- Trial name
- BASIC (NCT00345553)
- Where
- 16 sites in United States, Canada
- Volunteers
- 1,265 people
- Sponsor
- Arbor Research Collaborative for Health
Biliary Atresia, Cholangitis
Preventive Effect of Prophylactic Oral Antibiotics Against Cholangitis After Kasai Portoenterostomy
This study is non-inferiority trial design. This study aimed to investigate the effect of prophylactic oral antibiotics on preventing cholangitis in biliary atresia (BA) patients after Kasai portoenterostomy (KP) by comparing the…
- Conditions
- Biliary Atresia, Cholangitis, Anti-Bacterial Agents
- Trial name
- NCT05925309
- Testing
- Basic treatment: sulperazone + ursodeoxycholic acid + compound glycyrrhizin + methylprednisolone + vitamin AD , D , E , K + imipenem or meropenem, Prophylactic oral antibiotics: compound sulfamethoxazole tablet (SMZ/TMP) + cefaclor
- Where
- China
- Volunteers
- 356 people
- Sponsor
- Children's Hospital of Fudan University
Dental Diseases
Dental Dyschromia and Quality of Life in Early Prolonged Hyperbilirubinemia
The main objective of this study is to assess the prevalence of dental discoloration (dental dyschromia) in children who experienced high levels of bilirubin in their blood (hyperbilirubinemia) during their early years.
- Trial name
- SMILE (NCT06506734)
- Testing
- Questionnaires
- Where
- 9 sites in France
- Volunteers
- 120 people
- Sponsor
- University Hospital, Toulouse
Biliary Atresia
Use of Indocyanine Green (ICG) for the Diagnosis of Biliary Atresia
Biliary atresia is a rare, progressive liver disease that only affects infants. It leads to complete obstruction and scarring of the bile duct. Current non-invasive diagnostic tests have limited sensitivity.
- Trial name
- NCT07513038
- Testing
- Indocyanine Green (ICG)
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Boston Children's Hospital
Biliary Atresia, Infant
High Medium-chain Triglyceride Nutritional Support in Infants With Biliary Atresia
This study is a prospective, single center and observational open clinical study.
- Conditions
- Biliary Atresia, Infant, Nutrition Support, Medium-chain Triglyceride
- Trial name
- NCT05072626
- Where
- China
- Volunteers
- 300 people
- Sponsor
- Children's Hospital of Fudan University
Biliary Atresia, Prognosis
Preoperative Serum FGF19 in the Prognosis of Biliary Atresia
To investigate the role of preoperative serum FGF19 level in the prognosis of biliary atresia.
- Trial name
- NCT05848310
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Children's Hospital of Fudan University