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Showing 1–24 of 29 matching trials from the live ClinicalTrials.gov search.
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Filters: Condition: Cholestasis in Newborn Clear all
Completed Phase 4 Interventional Results available

Pediatric Study to Evaluate Risk of Developing Essential Fatty Acid Deficiency When Receiving Clinolipid or Standard-of-Care Lipid Emulsion (Part A)

NCT04555044
View directory record Official record
Conditions
Essential Fatty Acid Deficiency (EFAD)
Interventions
Clinolipid, Intralipid
Drug
Lead sponsor
Baxter Healthcare Corporation
Industry
Eligibility
0 Years to 17 Years
Enrollment
101 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2022
U.S. locations
9
States / cities
Mobile, Alabama • New Haven, Connecticut • Orlando, Florida + 6 more
Source: ClinicalTrials.gov public record
Updated Dec 26, 2023 · Synced Jun 26, 2026, 8:45 AM EDT
Terminated Phase 4 Interventional Results available

Low Dose Fat for the Prevention of Liver Disease in Babies With Gastrointestinal Disorders

NCT01373918
View directory record Official record
Conditions
Cholestasis
Interventions
Intralipid
Drug
Lead sponsor
University of California, Los Angeles
Other
Eligibility
1 Minute to 5 Days
Enrollment
41 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2014
U.S. locations
2
States / cities
Los Angeles, California • St Louis, Missouri
Source: ClinicalTrials.gov public record
Updated Jun 15, 2016 · Synced Jun 26, 2026, 8:45 AM EDT
Not listed Not applicable Interventional

Decreasing Hemorrhage Risk in Children With Alagille Syndrome

NCT05846854
View directory record Official record
Conditions
Alagille Syndrome, Pulmonary Artery Stenoses, Acquired Von Willebrand Disease
Interventions
Assessment for bleeding disorder with tailored post-operative care
Other
Lead sponsor
Stanford University
Other
Eligibility
Up to 17 Years
Enrollment
40 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2024
U.S. locations
1
States / cities
Palo Alto, California
Source: ClinicalTrials.gov public record
Updated May 5, 2023 · Synced Jun 26, 2026, 8:45 AM EDT
Terminated Phase 4 Interventional Results available

Pediatric Study to Evaluate Risk of Developing Essential Fatty Acid Deficiency When Receiving Clinolipid or Standard-of-Care Lipid Emulsion

NCT02476994
View directory record Official record
Conditions
Essential Fatty Acid Deficiency (EFAD)
Interventions
Clinolipid, Intralipid
Drug
Lead sponsor
Baxter Healthcare Corporation
Industry
Eligibility
Up to 17 Years
Enrollment
1 participant
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2016
U.S. locations
4
States / cities
Park Ridge, Illinois • Indianapolis, Indiana • Columbus, Ohio + 1 more
Source: ClinicalTrials.gov public record
Updated Jul 20, 2021 · Synced Jun 26, 2026, 8:45 AM EDT
Completed Not applicable Interventional Results available

Low Dose Parenteral Fat for Prevention of Parenteral Nutrition Associated Cholestasis in Preterm Neonates

NCT01050660
View directory record Official record
Conditions
Parenteral Nutrition-Associated Liver Disease
Interventions
Intravenous fat emulsion, Restriction of intravenous fat emulsion to 1 gm/kg/d
Other
Lead sponsor
Yale University
Other
Eligibility
12 Hours to 48 Hours
Enrollment
136 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2013
U.S. locations
1
States / cities
New Haven, Connecticut
Source: ClinicalTrials.gov public record
Updated Oct 27, 2014 · Synced Jun 26, 2026, 8:45 AM EDT
Recruiting Early Phase 1 Interventional Accepts healthy volunteers

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

NCT07250854
View directory record Official record
Conditions
Biliary Atresia, Kasai, Cholestasis in Newborn, Cholestasis in Newborn Infant
Interventions
Indocyanine Green
Drug
Lead sponsor
University of Alabama at Birmingham
Other
Eligibility
2 Weeks to 4 Months
Enrollment
15 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2026 – 2027
U.S. locations
1
States / cities
Birmingham, Alabama
Source: ClinicalTrials.gov public record
Updated Feb 17, 2026 · Synced Jun 26, 2026, 8:45 AM EDT
Recruiting Phase 3 Interventional

Long-term Safety and Efficacy of Odevixibat in Patients With Alagille Syndrome

NCT05035030
View directory record Official record
Conditions
Alagille Syndrome
Interventions
Odevixibat
Drug
Lead sponsor
Albireo, an Ipsen Company
Industry
Eligibility
Not listed
Enrollment
70 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2026
U.S. locations
18
States / cities
San Diego, California • San Francisco, California • Atlanta, Georgia + 14 more
Source: ClinicalTrials.gov public record
Updated May 27, 2026 · Synced Jun 26, 2026, 8:45 AM EDT
Completed Not applicable Interventional

Sincalide (Cholecystokinin Octapeptide) Versus Placebo in Neonates at High Risk for Developing Parenteral Nutrition Associated Cholestasis

NCT00004414
View directory record Official record
Conditions
Cholestasis
Interventions
sincalide
Drug
Lead sponsor
University of Michigan
Other
Eligibility
Up to 30 Days
Enrollment
252 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
1997 – 2002
U.S. locations
6
States / cities
Baltimore, Maryland • Ann Arbor, Michigan • Rochester, New York + 3 more
Source: ClinicalTrials.gov public record
Updated Mar 24, 2015 · Synced Jun 26, 2026, 8:45 AM EDT
Completed Phase 3 Interventional Results available

Compassionate Treatment of Patients With Inborn Errors of Bile Acid Metabolism With Cholic Acid

NCT00007020
View directory record Official record
Conditions
Infantile Refsum's Disease, Zellweger Syndrome, Adrenoleukodystrophy, Peroxisomal Disorders, Cholestasis
Interventions
Cholic Acids
Drug
Lead sponsor
Mirum Pharmaceuticals, Inc.
Industry
Eligibility
Not listed
Enrollment
85 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
1992 – 2009
U.S. locations
1
States / cities
Cincinnati, Ohio
Source: ClinicalTrials.gov public record
Updated Oct 2, 2023 · Synced Jun 26, 2026, 8:45 AM EDT
Completed No phase listed Observational

Characterization of Pulmonary Artery Stenoses in Alagille Syndrome - a Medical Record Review

NCT01515631
View directory record Official record
Conditions
Alagille Syndrome
Interventions
Not listed
Lead sponsor
Stanford University
Other
Eligibility
Not listed
Enrollment
25 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2007 – 2018
U.S. locations
1
States / cities
Palo Alto, California
Source: ClinicalTrials.gov public record
Updated Sep 27, 2018 · Synced Jun 26, 2026, 8:45 AM EDT
Recruiting No phase listed Observational

Biliary Atresia Study in Infants and Children

NCT00345553
View directory record Official record
Conditions
Biliary Atresia
Interventions
Not listed
Lead sponsor
Arbor Research Collaborative for Health
Other
Eligibility
6 Months to 20 Years
Enrollment
1,265 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2006 – 2029
U.S. locations
15
States / cities
Los Angeles, California • San Francisco, California • Aurora, Colorado + 12 more
Source: ClinicalTrials.gov public record
Updated Jun 3, 2026 · Synced Jun 26, 2026, 8:45 AM EDT
Completed Phase 2Phase 3 Interventional Results available

Compassionate Use of Omegaven in Children

NCT02370251
View directory record Official record
Conditions
Total Parenteral Nutrition-induced Cholestasis, Cholestasis, Short Bowel Syndrome, Gastroschisis, Intestinal Atresia, Infant, Premature, Diseases, Cholestasis of Parenteral Nutrition
Interventions
Omegaven
Drug
Lead sponsor
University of Oklahoma
Other
Eligibility
Up to 18 Years
Enrollment
63 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2019
U.S. locations
1
States / cities
Oklahoma City, Oklahoma
Source: ClinicalTrials.gov public record
Updated Nov 24, 2019 · Synced Jun 26, 2026, 8:45 AM EDT
Completed Phase 2 Interventional Results available

A Study to Evaluate the Safety and Tolerability of Maralixibat in Infant Participants With Cholestatic Liver Diseases Including Progressive Familial Intrahepatic Cholestasis (PFIC) and Alagille Syndrome (ALGS).

NCT04729751
View directory record Official record
Conditions
Progressive Familial Intrahepatic Cholestasis, Alagille Syndrome, Cholestatic Liver Disease
Interventions
Maralixibat
Drug
Lead sponsor
Mirum Pharmaceuticals, Inc.
Industry
Eligibility
0 Days to 364 Days
Enrollment
27 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2024
U.S. locations
7
States / cities
Los Angeles, California • San Francisco, California • Washington D.C., District of Columbia + 4 more
Source: ClinicalTrials.gov public record
Updated Jun 1, 2026 · Synced Jun 26, 2026, 8:45 AM EDT
Completed Phase 3 Interventional Results available

Efficacy and Safety of Odevixibat in Patients With Alagille Syndrome

NCT04674761
View directory record Official record
Conditions
Alagille Syndrome
Interventions
Odevixibat, Placebo
Drug
Lead sponsor
Albireo
Industry
Eligibility
Not listed
Enrollment
52 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2022
U.S. locations
9
States / cities
San Francisco, California • Baltimore, Maryland • Boston, Massachusetts + 5 more
Source: ClinicalTrials.gov public record
Updated Nov 1, 2023 · Synced Jun 26, 2026, 8:45 AM EDT
Completed Not applicable Interventional

Study of Magnesium Sulfate in Children With Reduced Bone Density Secondary to Chronic Cholestatic Liver Disease

NCT00007033
View directory record Official record
Conditions
Alagille Syndrome, Cholestasis, Biliary Atresia
Interventions
magnesium gluconate, magnesium sulfate
Drug
Lead sponsor
National Center for Research Resources (NCRR)
NIH
Eligibility
3 Years to 18 Years
Enrollment
25 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
Started 2000
U.S. locations
1
States / cities
Cincinnati, Ohio
Source: ClinicalTrials.gov public record
Updated Jan 21, 2009 · Synced Jun 26, 2026, 8:45 AM EDT
Completed No phase listed Observational Accepts healthy volunteers

Neurodevelopment and Neuroimaging in Parenterally-fed Infants and Young Children

NCT00392730
View directory record Official record
Conditions
Parenteral Nutrition, Necrotizing Enterocolitis, Digestive System Abnormalities, Cholestasis
Interventions
Remove Mn from PN if evidence of increased brain Mn on MRI
Dietary Supplement
Lead sponsor
Vanderbilt University
Other
Eligibility
30 Days to 6 Years
Enrollment
122 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2006 – 2010
U.S. locations
1
States / cities
Nashville, Tennessee
Source: ClinicalTrials.gov public record
Updated Dec 18, 2013 · Synced Jun 26, 2026, 8:45 AM EDT
Completed No phase listed Observational

FibroScan™ in Pediatric Cholestatic Liver Disease (FORCE)

NCT02922751
View directory record Official record
Conditions
Biliary Atresia, Alagille Syndrome, Alpha1 Anti-Trypsin Deficiency, Portal Hypertension, Liver Fibrosis, Cholestasis
Interventions
Liver Stiffness Measurement (LSM)
Other
Lead sponsor
Arbor Research Collaborative for Health
Other
Eligibility
Up to 21 Years
Enrollment
552 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2022
U.S. locations
12
States / cities
Los Angeles, California • San Francisco, California • Aurora, Colorado + 9 more
Source: ClinicalTrials.gov public record
Updated Aug 27, 2024 · Synced Jun 26, 2026, 8:45 AM EDT
Completed Phase 3 Interventional Results available

Comparison of Smoflipid to Soy-based Lipid Reduction for Cholestasis Prevention in Surgical Neonates

NCT03387579
View directory record Official record
Conditions
Cholestasis of Parenteral Nutrition
Interventions
Smoflipid 20% Lipid Emulsion for Injection, Intralipid, 20% Intravenous Emulsion
Drug
Lead sponsor
Indiana University
Other
Eligibility
Not listed
Enrollment
24 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2024
U.S. locations
1
States / cities
Indianapolis, Indiana
Source: ClinicalTrials.gov public record
Updated Jul 29, 2025 · Synced Jun 26, 2026, 8:45 AM EDT
Withdrawn No phase listed Observational Accepts healthy volunteers

Intestinal Microbiome Composition in Infants With Biliary Atresia (BA)

NCT03890536
View directory record Official record
Conditions
Biliary Atresia, Intrahepatic Cholestases, Normal Controls
Interventions
Not listed
Lead sponsor
Children's Hospital Medical Center, Cincinnati
Other
Eligibility
1 Day to 2 Years
Healthy volunteers
Accepts healthy volunteers
Timeline
2023 – 2032
U.S. locations
1
States / cities
Cincinnati, Ohio
Source: ClinicalTrials.gov public record
Updated Jul 8, 2025 · Synced Jun 26, 2026, 8:45 AM EDT
Recruiting No phase listed Observational

A Study Observing the Long-term, Effectiveness and Safety of Odevixibat (Bylvay) in Patients With Alagille Syndrome (ALGS) Who Are Receiving Ongoing Treatment

NCT06850038
View directory record Official record
Conditions
Alagille Syndrome
Interventions
Not listed
Lead sponsor
Ipsen
Industry
Eligibility
Not listed
Enrollment
30 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2029
U.S. locations
10
States / cities
Los Angeles, California • San Francisco, California • Kansas City, Missouri + 6 more
Source: ClinicalTrials.gov public record
Updated May 27, 2026 · Synced Jun 26, 2026, 8:45 AM EDT
Completed Phase 2 Interventional Results available

Evaluation of LUM001 in the Reduction of Pruritus in Alagille Syndrome

NCT02057692
View directory record Official record
Conditions
Alagille Syndrome
Interventions
LUM001, Placebo
Drug
Lead sponsor
Mirum Pharmaceuticals, Inc.
Industry
Eligibility
12 Months to 18 Years
Enrollment
37 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2016
U.S. locations
12
States / cities
Los Angeles, California • San Francisco, California • Aurora, Colorado + 9 more
Source: ClinicalTrials.gov public record
Updated Mar 25, 2019 · Synced Jun 26, 2026, 8:45 AM EDT
Terminated Not applicable Interventional

Prevention of Parenteral Nutrition-Associated Cholestasis With Cyclic Parenteral Nutrition in Infants

NCT01062815
View directory record Official record
Conditions
Cholestasis, Prematurity, Gastroschisis, Intestinal Atresia, Necrotizing Enterocolitis
Interventions
Parenteral Nutrition
Dietary Supplement
Lead sponsor
University of Miami
Other
Eligibility
Up to 7 Days
Enrollment
48 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2010
U.S. locations
1
States / cities
Miami, Florida
Source: ClinicalTrials.gov public record
Updated Nov 22, 2015 · Synced Jun 26, 2026, 8:45 AM EDT
Recruiting No phase listed Observational

Long-Term SafEty and Clinical Outcomes of LivmArli in Patients in the United States (LEAP-US)

NCT06193928
View directory record Official record
Conditions
Alagille Syndrome, Progressive Familial Intrahepatic Cholestasis
Interventions
Livmarli
Drug
Lead sponsor
Mirum Pharmaceuticals, Inc.
Industry
Eligibility
Not listed
Enrollment
70 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2030
U.S. locations
8
States / cities
Los Angeles, California • Aurora, Colorado • Atlanta, Georgia + 5 more
Source: ClinicalTrials.gov public record
Updated May 24, 2025 · Synced Jun 26, 2026, 8:45 AM EDT