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Showing 1–24 of 27 matching trials from the live ClinicalTrials.gov search.
Local D1 index available.
Filters: Condition: Cholestatic Liver Disease Clear all
Completed Phase 2 Interventional Results available

Open Label Study to Evaluate Efficacy and Long Term Safety of LUM001 (Maralixibat) in the Treatment of Cholestatic Liver Disease in Patients With Progressive Familial Intrahepatic Cholestasis

NCT02057718
View directory record Official record
Conditions
Progressive Familial Intrahepatic Cholestasis (PFIC)
Interventions
LUM001 (Maralixibat)
Drug
Lead sponsor
Mirum Pharmaceuticals, Inc.
Industry
Eligibility
12 Months to 18 Years
Enrollment
33 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2020
U.S. locations
5
States / cities
Los Angeles, California • Aurora, Colorado • Cincinnati, Ohio + 2 more
Source: ClinicalTrials.gov public record
Updated Oct 22, 2023 · Synced Jul 22, 2026, 8:18 PM EDT
Recruiting Phase 1 Interventional

Evaluate PK & Safety of Saroglitazar in Subjects With Moderate Hepatic Impairment Due to Cholestatic Liver Disease

NCT06825559
View directory record Official record
Conditions
Cholestatic Liver Disease
Interventions
Saroglitazar Magnesium 1 mg
Drug
Lead sponsor
Zydus Therapeutics Inc.
Industry
Eligibility
18 Years to 80 Years
Enrollment
6 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025
U.S. locations
1
States / cities
Indianapolis, Indiana
Source: ClinicalTrials.gov public record
Updated Oct 23, 2025 · Synced Jul 22, 2026, 8:18 PM 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 Jul 22, 2026, 8:18 PM EDT
Completed No phase listed Observational

Genetic Epidemiology of Primary Biliary Cirrhosis (PBC)

NCT01161953
View directory record Official record
Conditions
Primary Biliary Cirrhosis
Interventions
Genetic Analysis
Genetic
Lead sponsor
Mayo Clinic
Other
Eligibility
18 Years to 90 Years
Enrollment
1,500 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2002 – 2025
U.S. locations
1
States / cities
Rochester, Minnesota
Source: ClinicalTrials.gov public record
Updated Sep 28, 2025 · Synced Jul 22, 2026, 8:18 PM EDT
Completed Phase 2 Interventional Results available

An Extension Study to Evaluate the Long-Term Safety and Durability of Effect of LUM001 in the Treatment of Cholestatic Liver Disease in Pediatric Subjects With Alagille Syndrome

NCT02117713
View directory record Official record
Conditions
Alagille Syndrome
Interventions
LUM001 (Maralixibat)
Drug
Lead sponsor
Mirum Pharmaceuticals, Inc.
Industry
Eligibility
1 Year to 18 Years
Enrollment
34 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2020
U.S. locations
10
States / cities
Los Angeles, California • San Francisco, California • Aurora, Colorado + 7 more
Source: ClinicalTrials.gov public record
Updated Jun 30, 2021 · Synced Jul 22, 2026, 8:18 PM EDT
Recruiting No phase listed Observational Accepts healthy volunteers

DILIN - Prospective Study

NCT00345930
View directory record Official record
Conditions
Liver Diseases
Interventions
Not listed
Lead sponsor
Duke University
Other
Eligibility
2 Years and older
Enrollment
4,000 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2004 – 2028
U.S. locations
6
States / cities
Los Angeles, California • Indianapolis, Indiana • Bethesda, Maryland + 3 more
Source: ClinicalTrials.gov public record
Updated Apr 7, 2026 · Synced Jul 22, 2026, 8:18 PM EDT
Completed Phase 1 Interventional

Safety and Efficacy Study of Ursodeoxycholic Acid Therapy in Pediatric Primary Sclerosing Cholangitis

NCT01088607
View directory record Official record
Conditions
Primary Sclerosing Cholangitis
Interventions
ursodeoxycholic acid (UDCA)
Drug
Lead sponsor
University of Tennessee
Other
Eligibility
5 Years to 21 Years
Enrollment
27 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2017
U.S. locations
12
States / cities
Phoenix, Arizona • Los Angeles, California • San Francisco, California + 9 more
Source: ClinicalTrials.gov public record
Updated Oct 25, 2017 · Synced Jul 22, 2026, 8:18 PM EDT
Recruiting No phase listed Observational

Drug-Induced Liver Injury (DILI) Network Retrospective

NCT00360646
View directory record Official record
Conditions
Drug Induced Liver Injury
Interventions
Not listed
Lead sponsor
Duke University
Other
Eligibility
2 Years and older
Enrollment
400 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2004 – 2028
U.S. locations
6
States / cities
Los Angeles, California • Indianapolis, Indiana • Bethesda, Maryland + 3 more
Source: ClinicalTrials.gov public record
Updated Apr 7, 2026 · Synced Jul 22, 2026, 8:18 PM EDT
Recruiting No phase listed Observational Accepts healthy volunteers

Biobank for Cholestatic Liver Diseases.

NCT03445585
View directory record Official record
Conditions
Primary Sclerosing Cholangitis, Primary Biliary Cirrhosis, Cholangiocarcinoma, Liver Cancer
Interventions
Not listed
Lead sponsor
Mayo Clinic
Other
Eligibility
18 Years to 85 Years
Enrollment
9,150 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2017 – 2050
U.S. locations
1
States / cities
Rochester, Minnesota
Source: ClinicalTrials.gov public record
Updated Feb 16, 2026 · Synced Jul 22, 2026, 8:18 PM EDT
Completed Phase 1 Interventional

Hepatic Impairment, Cholestatic Liver Disease, & NASH with Advanced Fibrosis & Normal Hepatic Function

NCT04469920
View directory record Official record
Conditions
Hepatic Impairment
Interventions
Saroglitazar Magnesium 2 mg, Saroglitazar Magnesium 4 mg
Drug
Lead sponsor
Zydus Therapeutics Inc.
Industry
Eligibility
18 Years to 80 Years
Enrollment
98 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2022
U.S. locations
2
States / cities
Indianapolis, Indiana • San Antonio, Texas
Source: ClinicalTrials.gov public record
Updated Sep 19, 2024 · Synced Jul 22, 2026, 8:18 PM 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 Jul 22, 2026, 8:18 PM EDT
Completed Phase 2 Interventional Results available

MRX-800: A Long-Term Safety Study of Maralixibat in the Treatment of Cholestatic Liver Disease in Subjects Who Previously Participated in a Maralixibat Study

NCT04168385
View directory record Official record
Conditions
Cholestatic Liver Disease
Interventions
Maralixibat
Drug
Lead sponsor
Mirum Pharmaceuticals, Inc.
Industry
Eligibility
12 Months and older
Enrollment
52 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2024
U.S. locations
6
States / cities
Los Angeles, California • Indianapolis, Indiana • Philadelphia, Pennsylvania + 3 more
Source: ClinicalTrials.gov public record
Updated Dec 7, 2025 · Synced Jul 22, 2026, 8:18 PM EDT
Recruiting Phase 2 Interventional

A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Biliary Cholangitis

NCT05050136
View directory record Official record
Conditions
Primary Biliary Cholangitis, PBC
Interventions
Volixibat, Placebo
Drug
Lead sponsor
Mirum Pharmaceuticals, Inc.
Industry
Eligibility
18 Years and older
Enrollment
260 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2027
U.S. locations
44
States / cities
Coronado, California • Los Angeles, California • Sacramento, California + 38 more
Source: ClinicalTrials.gov public record
Updated May 13, 2026 · Synced Jul 22, 2026, 8:18 PM EDT
Active, not recruiting No phase listed Observational Accepts healthy volunteers

Osmotic Fragility in Red Blood Cells of Pediatric Patients With Cholestatic Liver Disease

NCT05582447
View directory record Official record
Conditions
Cholestasis, Red Cell Membrane and Enzyme Abnormalities
Interventions
ektacytometry of red blood cells
Other
Lead sponsor
Children's Hospital Medical Center, Cincinnati
Other
Eligibility
1 Year and older
Enrollment
40 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2018 – 2027
U.S. locations
1
States / cities
Cincinnati, Ohio
Source: ClinicalTrials.gov public record
Updated Feb 5, 2026 · Synced Jul 22, 2026, 8:18 PM EDT
Recruiting Phase 1 Interventional Accepts healthy volunteers

Hepatic Impairment With Cirrhosis Due to Cholestatic Liver Disease

NCT05045482
View directory record Official record
Conditions
Hepatic Impairment, Cirrhosis, Cholestatic Liver Disease
Interventions
Saroglitazar Magnesium 1 mg, Saroglitazar Magnesium 2 mg
Drug
Lead sponsor
Zydus Therapeutics Inc.
Industry
Eligibility
18 Years to 80 Years
Enrollment
30 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2021 – 2026
U.S. locations
1
States / cities
Indianapolis, Indiana
Source: ClinicalTrials.gov public record
Updated Feb 16, 2026 · Synced Jul 22, 2026, 8:18 PM EDT
Completed No phase listed Observational

Validation of the Itch Reported Outcome (ItchRO) Diaries in Pediatric Cholestatic Liver Disease

NCT02131623
View directory record Official record
Conditions
Alagille Syndrome, Progressive Familial Intrahepatic Cholestasis
Interventions
Not listed
Lead sponsor
Mirum Pharmaceuticals, Inc.
Industry
Eligibility
5 Years and older
Enrollment
23 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2015
U.S. locations
4
States / cities
Phoenix, Arizona • Aurora, Colorado • St Louis, Missouri + 1 more
Source: ClinicalTrials.gov public record
Updated Mar 17, 2019 · Synced Jul 22, 2026, 8:18 PM EDT
Approved For Marketing No phase listed Expanded access

A Maralixibat Expanded Access Program for Patients With Cholestatic Pruritus Associated With Alagille Syndrome (ALGS)

NCT04530994
View directory record Official record
Conditions
Alagille Syndrome
Interventions
maralixibat
Drug
Lead sponsor
Mirum Pharmaceuticals, Inc.
Industry
Eligibility
12 Months and older
U.S. locations
14
States / cities
Los Angeles, California • Redwood City, California • San Francisco, California + 11 more
Source: ClinicalTrials.gov public record
Updated Oct 19, 2021 · Synced Jul 22, 2026, 8:18 PM EDT
Completed No phase listed Observational

Genomics of Primary Sclerosing Cholangitis (PSC)

NCT01161992
View directory record Official record
Conditions
Primary Sclerosing Cholangitis (PSC)
Interventions
Genetic Analysis
Genetic
Lead sponsor
Mayo Clinic
Other
Eligibility
5 Years to 90 Years
Enrollment
1,500 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2002 – 2025
U.S. locations
1
States / cities
Rochester, Minnesota
Source: ClinicalTrials.gov public record
Updated Aug 6, 2025 · Synced Jul 22, 2026, 8:18 PM EDT
Suspended No phase listed Observational

Longitudinal Study of Genetic Causes of Intrahepatic Cholestasis (LOGIC)

NCT00571272
View directory record Official record
Conditions
Liver Diseases, Alagille Syndrome, Alpha 1-Antitrypsin Deficiency
Interventions
Not listed
Lead sponsor
Arbor Research Collaborative for Health
Other
Eligibility
Up to 25 Years
Enrollment
1,675 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2007 – 2029
U.S. locations
16
States / cities
Los Angeles, California • San Francisco, California • Aurora, Colorado + 12 more
Source: ClinicalTrials.gov public record
Updated Jun 3, 2026 · Synced Jul 22, 2026, 8:18 PM 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 Jul 22, 2026, 8:18 PM EDT
Active, not recruiting Phase 3 Interventional

Linerixibat Long-term Safety, and Tolerability Study

NCT04167358
View directory record Official record
Conditions
Cholestasis
Interventions
Linerixibat
Drug
Lead sponsor
GlaxoSmithKline
Industry
Eligibility
18 Years to 80 Years
Enrollment
242 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2026
U.S. locations
11
States / cities
Davis, California • West Hollywood, California • Miami, Florida + 8 more
Source: ClinicalTrials.gov public record
Updated Jun 21, 2026 · Synced Jul 22, 2026, 8:18 PM EDT
Active, not recruiting Phase 3 Interventional

Evaluation of Maralixibat in Pruritus Associated With General Cholestatic Liver Disease (EXPAND)

NCT06553768
View directory record Official record
Conditions
Cholestatic Liver Disease (Except ALGS, PFIC, PBC and PSC)
Interventions
Maralixibat, Placebo
Drug · Other
Lead sponsor
Mirum Pharmaceuticals, Inc.
Industry
Eligibility
6 Months and older
Enrollment
90 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2027
U.S. locations
9
States / cities
Los Angeles, California • Palo Alto, California • Chicago, Illinois + 4 more
Source: ClinicalTrials.gov public record
Updated Mar 29, 2026 · Synced Jul 22, 2026, 8:18 PM EDT
Terminated Phase 2 Interventional

Study to Evaluate the Safety and Efficacy of Oral CR845 (Difelikefalin) in Patients With Primary Biliary Cholangitis (PBC) and Moderate-to-Severe Pruritus

NCT03995212
View directory record Official record
Conditions
Cholestatic Pruritus
Interventions
CR845 1.0 mg, Placebo
Drug
Lead sponsor
Cara Therapeutics, Inc.
Industry
Eligibility
18 Years to 80 Years
Enrollment
14 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2022
U.S. locations
14
States / cities
Coronado, California • Rialto, California • San Francisco, California + 10 more
Source: ClinicalTrials.gov public record
Updated Jul 2, 2023 · Synced Jul 22, 2026, 8:18 PM EDT
Not listed Phase 2 Interventional

Phase II Pilot Study to Compare the Bioavailability of Buffered, Enteric-Coated Ursodiol With Unmodified Ursodiol for Chronic Cholestatic Liver Disease and Cystic Fibrosis-Associated Liver Disease

NCT00004315
View directory record Official record
Conditions
Cystic Fibrosis, Gastrointestinal Diseases, Cholestasis
Interventions
ursodiol
Drug
Lead sponsor
National Center for Research Resources (NCRR)
NIH
Eligibility
4 Months and older
Enrollment
20 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
Started 1995
U.S. locations
1
States / cities
Cincinnati, Ohio
Source: ClinicalTrials.gov public record
Updated Jun 23, 2005 · Synced Jul 22, 2026, 8:18 PM EDT