Cholestasis: Clinical Trials

178 completed, 61 unknown, 46 recruiting, 34 terminated. 93 Phase 2, 73 Phase 3, 58 Not applicable, 35 Phase 1, 26 Phase 4.

By phase and status

Phase	Trials	Status
Phase 2	93	Completed 50, Terminated 16, Unknown 8, Not yet recruiting 5, Withdrawn 5, Active not recruiting 4, Recruiting 4, Enrolling by invitation 1
Phase 3	73	Completed 37, Recruiting 12, Unknown 9, Active not recruiting 7, Terminated 3, Withdrawn 3, Enrolling by invitation 1, Not yet recruiting 1
Not applicable	58	Completed 28, Unknown 16, Terminated 7, Withdrawn 4, Active not recruiting 1, Not yet recruiting 1, Recruiting 1
Phase 1	35	Completed 25, Unknown 3, Not yet recruiting 2, Terminated 2, Withdrawn 2, Recruiting 1
Phase 4	26	Completed 10, Unknown 9, Terminated 4, Recruiting 3
Early Phase 1	5	Completed 2, Active not recruiting 1, Recruiting 1, Unknown 1

Follow Cholestasis: new trials by email Literature Review of Cholestasis trials Research Report on Cholestasis

Trials newest first · largest first

Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.

Trial	Phase	Status	Sponsor	Enrollment	Start	Updated
A Study of Fatigue, Itching and Daily Activities in People With Primary Biliary Cholangitis Starting Elafibranor Elafibranor - Primary Biliary Cholangitis (PBC)		Not yet recruiting	Ipsen	50	2026-11-02	2026-10-30
Nemolizumab for the Treatment of Moderate to Severe Chronic Hepatic Pruritus Nemolizumab-ilto - Chronic Hepatic Pruritus, Cholestatic Liver Disease	Phase 2	Not yet recruiting	Mayo Clinic	15	2026-11-01	2026-09-28
J-LINX: Japan LINerixibat eXtension Study Linerixibat - Pruritus	Phase 3	Not yet recruiting	GlaxoSmithKline	40	2026-10-09	2026-10-06
Tolerability of Enteral NAC in Infants N-Acetylcysteine - Biliary Atresia	Phase 1	Not yet recruiting	Sanjiv Harpavat	12	2026-10-01	2026-03-04
Study of Seladelpar and Cilofexor in Participants With Primary Biliary Cholangitis Seladelpar, PTM Seladelpar, Cilofexor Dose B - Primary Biliary Cholangitis	Phase 2	Recruiting	Gilead Sciences	132	2026-10-01	2026-10-27
Phase I/II Trial of Human Umbilical Cord Mesenchymal Stromal Cells for UDCA-Refractory Primary Biliary Cholangitis Standard background therapy, Placebo, hUC-MSC Dose Level 1 - Primary Biliary Cholangitis	Phase 1 / Phase 2	Not yet recruiting	Beijing 302 Hospital	68	2026-08-31	2026-08-31
Study of Saroglitazar Magnesium for PBC Patients With Incomplete Response or Intolerant to UDCA Therapy Saroglitazar Magnesium 1 mg, Placebo - Primary Biliary Cholangitis	Phase 3	Recruiting	Zydus Therapeutics Inc.	90	2026-08-11	2026-09-15
Determine the Prevalence of Exocrine Pancreatic Insufficiency (EPI) in Pediatric and Adult Participants With Alagille Syndrome After Liver Transplantation Fecal Fat - Exocrine Pancreatic Insuficiency		Recruiting	Digestive Care, Inc.	30	2026-08-03	2026-10-27
Study on Clinical and Pathological Features of Primary Biliary Cholangitis and Risk Factors Related to Disease Progression PBC		Not yet recruiting	Beijing Municipal Administration of Hospitals	300	2026-08-01	2026-08-04
Elafibranor Pregnancy Surveillance Program: A Study to Evaluate the Safety of Elafibranor During Pregnancy Elafibranor - Pregnancy Related		Recruiting	Ipsen	3	2026-07-29	2026-10-23
A Study to Observe the Long-term Safety of Odevixibat in Patients With Alagille Syndrome (ALGS) Who Are Receiving Ongoing Treatment Alagille Syndrome		Recruiting	Ipsen	30	2026-07-10	2026-10-23
LEOPARD Prospective Validation Cohort 1 Standardized assessments, guided tumor biopsy and biobanking, Standardized assessments and biobanking - Decompensated Liver Cirrhosis, Primary Biliary Cholangitis		Recruiting	Assistance Publique - Hôpitaux de Paris	630	2026-07-07	2026-07-29
Using Digital Health Technology to Monitor Patients With Primary Biliary Cholangitis (PBC) Primary Biliary Cholangitis (PBC)		Enrolling by invitation	Stanford University	30	2026-07-01	2026-06-11
The Value of Spleen Stiffness Measurement in Patients With PBC Spleen stiffness measurement - Primary Biliary Cholangitis, Spleen Stiffness	Not applicable	Not yet recruiting	Universitair Ziekenhuis Brussel	125	2026-07-01	2026-05-01
TH104 for the Treatment of Pruritus in Primary Biliary Cholangitis Nalmefene, Placebo - Pruritus, Primary Biliary Cholangitis	Phase 2	Not yet recruiting	Tharimmune Inc	40	2026-06-01	2025-09-09
The Safety and Efficacy of Upadacitinib in Refractory Autoimmune Related Cholangitis and Atopic Dermatitis With Moderate to Severe Itching Upadacitinib 15 MG - Primary Biliary Cholangitis (PBC), Primary Sclerosing Cholangitis (PSC)	Phase 2	Not yet recruiting	RenJi Hospital	44	2026-06-01	2026-07-01
Patients With Primary Biliary Cholangitis(PBC) Primary Biliary Cholangitis, Liver Fibrosis		Active not recruiting	Fondazione Policlinico Universitario Agostino Gemelli IRCCS	30	2026-05-18	2026-06-05
Vitamin D2 vs Vitamin D2 Plus Calcitriol in Cholestatic Children With Vitamin D Deficiency Vitamin D2, Calcitriol - Cholestatic Liver Disease, Chronic Liver Disease (CLD)	Phase 4	Recruiting	Chulalongkorn University	54	2026-04-28	2026-08-03
Patients With Primary Biliary Cholangitis Reflex AMA and ANA testing - Primary Biliary Cholangitis, Intrahepatic Bile Duct Cancer	Not applicable	Active not recruiting	Fondazione Policlinico Universitario Agostino Gemelli IRCCS	2000	2026-04-23	2026-05-07
Pediatric Evaluation and Registry for Liver Cholestasis in Canada PFIC - Progressive Familial Intrahepatic Cholestasis, Alagille Syndrome (ALGS)		Recruiting	Children's Hospital of Eastern Ontario	220	2026-04-21	2026-10-08

Showing 20 of 387. Sign in to see all of them.

Narrower conditions

Liver Cirrhosis, Biliary (214)  ·  Alagille Syndrome (31)  ·  Liver Diseases (26)  ·  Pruritus (26)  ·  Cholangitis, Sclerosing (23)  ·  Cholestasis, progressive familial intrahepatic 1 (19)  ·  Hyperphagia (18)  ·  Cholestasis, Extrahepatic (16)  ·  Cholestasis, Intrahepatic (15)  ·  Fibrosis (15)  ·  Hepatitis, Autoimmune (14)  ·  Biliary Atresia (13)  ·  Bile Duct Diseases (12)  ·  Cholangitis (12)

Broader conditions

Digestive System Diseases (379)  ·  Biliary Tract Diseases (378)  ·  Bile Duct Diseases (375)  ·  Pathological Conditions, Signs and Symptoms (276)  ·  Pathologic Processes (246)  ·  Liver Diseases (245)  ·  Cholestasis, Intrahepatic (239)  ·  Liver Cirrhosis (205)  ·  Fibrosis (202)  ·  Signs and Symptoms (64)  ·  Congenital, Hereditary, and Neonatal Diseases and Abnormalities (55)  ·  Congenital Abnormalities (48)  ·  Cardiovascular Diseases (38)  ·  Skin Manifestations (35)

Interventions

Ursodeoxycholic Acid (33)  ·  fish oil triglycerides (23)  ·  maralixibat (13)  ·  obeticholic acid (13)  ·  Fenofibrate (12)  ·  seladelpar (8)  ·  2-(2,6-dimethyl-4-(3-(4-(methylthio)phenyl)-3-oxo-1-propenyl)phenoxyl)-2-methylpropanoic acid (7)  ·  Bezafibrate (7)  ·  saroglitazar (6)  ·  soybean oil, phospholipid emulsion (6)  ·  odevixibat (5)  ·  Blood Specimen Collection (4)  ·  Cholangiopancreatography, Endoscopic Retrograde (4)  ·  SMOFlipid (4)  ·  Surveys and Questionnaires (4)

Sponsors

Mirum Pharmaceuticals, Inc. (20)  ·  Xijing Hospital of Digestive Diseases (12)  ·  Intercept Pharmaceuticals (11)  ·  Ipsen (11)  ·  Gilead Sciences (10)  ·  GlaxoSmithKline (10)  ·  Mayo Clinic (8)  ·  University of Aarhus (7)  ·  University of Alberta (7)  ·  Zydus Therapeutics Inc. (6)  ·  Albireo (5)  ·  Cascade Pharmaceuticals, Inc (5)  ·  National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (5)  ·  West China Hospital (5)  ·  Arbor Research Collaborative for Health (4)

Countries

United States (166)  ·  China (59)  ·  United Kingdom (58)  ·  Canada (57)  ·  Germany (50)  ·  France (45)  ·  Italy (40)  ·  Spain (39)  ·  Belgium (31)  ·  Poland (24)  ·  Australia (23)  ·  Netherlands (23)  ·  South Korea (21)  ·  Argentina (18)  ·  Austria (18)

Top investigators

Li Yang, MD (5)  ·  Ed Doo, MD (4)  ·  Lisa Henn, PhD (4)  ·  Christopher L Bowlus, MD (3)  ·  Katrina Loh, MD (3)  ·  Michel Kahaleh, MD (3)  ·  Andreas Repa, MD (2)  ·  Christian Weyer, MD (2)  ·  Cynthia Levy, MD (2)  ·  Daniel Schmitz, MD (2)  ·  Deven Parmar (2)

Results publications

PMID 25543678, PMID 38780109, PMID 42002216, PMID 26561627, PMID 28249726, PMID 32059815, PMID 32716060, PMID 33006765, PMID 33038344, PMID 34695449, PMID 37953500, PMID 40439725, PMID 10022591, PMID 10051462, PMID 10102814, PMID 10343514, PMID 10347106, PMID 10655252, PMID 11906641, PMID 12183720, PMID 12360466, PMID 15017671, PMID 15128074, PMID 15269615, PMID 15468571, PMID 15672074, PMID 16299032, PMID 16530513, PMID 16564862, PMID 16848809, PMID 16863557, PMID 17058231, PMID 17399846, PMID 17680647, PMID 18041714, PMID 18310188, PMID 18752324, PMID 18778710, PMID 19458352, PMID 19491853, PMID 19554543, PMID 19661785, PMID 19687773, PMID 19782361, PMID 19957034, PMID 20393276, PMID 20493485, PMID 20531018, PMID 20578265, PMID 21034892

NIH funding

2016 (5), U01DK062436 (4), U01DK062445 (4), U01DK062452 (4), U01DK062453 (4), U01DK062456 (4), U01DK062466 (4), U01DK062470 (4), U01DK062481 (4), U01DK062497 (4), U01DK062500 (4), U01DK062503 (4), U01DK084536 (4), U01DK084538 (4), U01DK084575 (4)