Primary Biliary Cholangitis (DBCOND0080519)

Identifiers

Synonyms
Primary Biliary Cholangitis (PBC) / Biliary Cirrhosis, Primary / Biliary cirrhosis primary / Primary Biliary Cirrhosis / Primary Biliary Cirrhosis (PBC) / PBC / Primary biliary cholangitis / Hanot's cirrhosis / Primary biliary cholangitis (disorder) / Biliary cirrhosis (disorder) / Chronic non-suppurative destructive cholangitis

Associated Data

Indicated Drugs and Targets
DrugDescriptionTargets
Elafibranor
A peroxisome proliferator-activated receptor agonist used to treat primary biliary cholangitis in adults with intolerance of inadequate response to ursodeoxycholic acid.
Obeticholic acid
A bile acid analog and farnesoid X receptor agonist used to treat primary biliary cholangitis in adult patients with inadequate clinical response or intolerance to UDCA.
Seladelpar
A PPAR-delta agonist used to treat primary biliary cholangitis alone or in combination with ursodeoxycholic acid in adults.
Ursodeoxycholic acid
A bile acid used for the treatment of primary biliary cirrhosis (PBC).
Clinical Trials
IdentifierTitleDrug(s)PurposePhaseStatus
NCT06016842
A Long-Term Study of Elafibranor in Adult Participants With Primary Biliary Cholangitistreatment3recruiting
NCT06604923
PET/CT Scans Using the Tracer 11C-Csar, a Bile Acid Analog, to Depict and Visualize Changes in the Hepatobiliary System in Patients With Primary Biliary Cholangitis Before and After Treatment.No drug interventionsNot AvailableNot Availableactive_not_recruiting
NCT06591455
A Pilot Study of Fenofibrate and Ursodeoxycholic Acid in the Treatment of Newly Diagnosed Primary Biliary Cholangitistreatment0not_yet_recruiting
NCT06591468
A Multicenter, Randomized, Controlled Trial of Prednisone Combined with Ursodeoxycholic Acid in the Treatment of Primary Biliary Cholangitis with Moderate to Severe Interface Hepatitis Characteristicstreatment2 / 3not_yet_recruiting
NCT05896124
CS0159 in Chinese Patients With PBC (Primary Biliary Cholangitis)treatment2recruiting
NCT04047160
Safety, Tolerability of OP-724 in Patients With Primary Biliary Cholangitis (Phase I)treatment1completed
NCT03521297
Probiotics in PBC Patients of Poor Response to UDCAtreatment2unknown_status
NCT03188146
Performance of Scoring Systems in Chinese Patients With Primary Biliary Cholangitis (PBC) on Ursodeoxycholic AcidNot AvailableNot Availablerecruiting
NCT03124108
Study to Evaluate the Efficacy and Safety of Elafibranor in Patients With Primary Biliary Cholangitis (PBC) and Inadequate Response to Ursodeoxycholic Acidtreatment2completed
NCT00145964
Identification of the Genetic Variants Responsible for Primary Biliary Cirrhosis (PBC)No drug interventionsNot AvailableNot Availableunknown_status
NCT02360852
IBAT Inhibitor A4250 for Cholestatic Pruritustreatment2terminated
NCT02932449
A 5-year Longitudinal Observational Study of Patients With Primary Biliary CholangitisNo drug interventionsNot AvailableNot Availableactive_not_recruiting
NCT00242125
Family Studies in Primary Biliary Cirrhosis (PBC)No drug interventionsNot AvailableNot Availableunknown_status
NCT04526665
Study of Elafibranor in Patients With Primary Biliary Cholangitis (PBC)treatment3active_not_recruiting
NCT02916290
Fuzhenghuayu in Combination With Ursodeoxycholic Acid in Primary Biliary Cirrhosistreatment3unknown_status
NCT00844402
Safety and Efficacy of Long-Term Treatment With Atorvastatin in Patients With Primary Biliary Cirrhosistreatment3completed
NCT00588302
Moexipril for Primary Biliary Cirrhosistreatment2completed
NCT03941184
Spontaneous Coronary Artery Dissection (SCAD) and AutoimmunityNo drug interventionsNot AvailableNot Availablecompleted
NCT02823353
Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cirrhosistreatment3completed
NCT01161953
Genetic Epidemiology of Primary Biliary Cirrhosis (PBC)No drug interventionsNot AvailableNot Availableactive_not_recruiting
NCT00805805
Study Comparing Tetrathiomolybdate vs Standard Treatment in Primary Biliary Cirrhosistreatment3completed
NCT02965911
Efficacy and Safety of Fenofibrate Combined With UDCA in PBC Patients With an Incomplete Biochemical Response to UDCAtreatment1 / 2withdrawn
NCT04893993
PBC Induced Fatigue Treated With Thiaminetreatment4unknown_status
NCT03445585
Biobank for Cholestatic Liver Diseases.No drug interventionsNot AvailableNot Availablerecruiting
NCT00393185
Stem Cell Transplantation in Patients With Primary Biliary CirrhosisNo drug interventionstreatment1withdrawn
NCT04604652
Open-Label Study of HTD1801 in Adult Subjects With Primary Biliary CholangitisNo drug interventionstreatment2completed
NCT00575042
Use of Fenofibrate for Primary Biliary Cirrhosistreatment2completed
NCT01603199
High-protein High-fiber Diet in Patients With Primary Biliary CirrhosisNo drug interventionssupportive_careNot Availablecompleted
NCT02931513
sCD163 in PBC Patients - Assessment of Treatment ResponseNo drug interventionsNot AvailableNot Availablerecruiting
NCT00587119
Oral Budesonide in the Treatment of Patients With Primary Biliary Cirrhosis and Overlap Features of Autoimmune HepatitistreatmentNot Availablewithdrawn
NCT00364819
Initial Study of Rituximab to Treat Primary Biliary Cirrhosistreatment1 / 2completed
NCT02916641
Fuzhenghuayu for Patients With PBC Who Had An Inadequate Response to Ursodeoxycholic Acidtreatment3unknown_status
NCT02659696
Nalfurafine Hydrochloride for Pruritus in Patients With Primary Biliary CholangitisNo drug interventionsNot AvailableNot Availablecompleted
NCT02376335
B-Cell Depleting Therapy (Rituximab) as a Treatment for Fatigue in Primary Biliary Cirrhosistreatment2completed
NCT03590886
Gut Microbes and Metabolic Group in Different PBC Patients for UDCA ResponseNo drug interventionsNot AvailableNot Availablecompleted
NCT00746486
Ursodeoxycholic Acid Plus Budesonide Versus Ursodeoxycholic Acid Alone in Primary Biliary Cirrhosis (PBC)treatment3terminated
NCT02823366
Fenofibrate for Patients With Primary Biliary Cirrhosis Who Had An Inadequate Response to Ursodeoxycholic Acidtreatment3unknown_status
NCT04514965
Bezafibrate in Patients With Primary Biliary Cholangitis (PBC)No drug interventionsNot AvailableNot Availablerecruiting
NCT03337074
Paternally Inherited Phenotypes in CholestasisNo drug interventionsNot AvailableNot Availableunknown_status
NCT00490620
Study of Combivir for Patients With Primary Biliary Cirrhosistreatment2 / 3completed
NCT01389973
A Study of Efficacy and Safety of Ustekinumab in Patients With Primary Biliary Cirrhosis (PBC) Who Had an Inadequate Response to Ursodeoxycholic Acidtreatment2completed
NCT01662973
Umbilical Cord Mesenchymal Stem Cells for Patients With Primary Biliary CirrhosisNo drug interventionstreatment1 / 2unknown_status
NCT04791527
Online Wellness Intervention for Primary Biliary Cholangitis (PBC)No drug interventionstreatmentNot Availablecompleted
NCT00943176
Modafinil in the Treatment of Fatigue in Patients With Primary Biliary Cirrhosis (PBC)treatment1completed
NCT02193360
Pilot Study of FFP104 Dose Escalation in PBC SubjectsNo drug interventionstreatment1 / 2unknown_status
NCT01510860
Ursofalk Tablets (500 mg) Versus Ursofalk Capsules (250 mg) in the Treatment of Primary Biliary Cirrhosistreatment4completed
NCT02557360
Effectiveness of S-adenosyl-L-methionine in Patients With Primary Biliary CirrhosisNo drug interventionstreatment4completed
NCT01249092
Pentoxifylline for Primary Biliary Cirrhosistreatment2completed
NCT04933292
A Randomised Clinical Trial Assessing the Efficacy and Safety of Mycophenolate Mofetil Versus Azathioprine for Induction of Remission in Treatment Primary Biliary Cholangitis-Autoimmune Hepatitis Overlap Syndrometreatment4unknown_status
NCT03226067
Study to Assess Safety & Efficacy of GKT137831 in Patients With Primary Biliary Cholangitis Receiving Ursodiol.treatment2completed
NCT02924701
sCD163 in PBC Patients - Assessment of Disease Severity and PrognosisNo drug interventionsNot AvailableNot Availableactive_not_recruiting
NCT03743272
Repeatability and Reproducibility of Multiparametric MRINo drug interventionsNot AvailableNot Availableunknown_status
NCT04522869
Umbilical Cord Derived Mesenchymal Stem Cell (UC -MSC) Transplantation for Children Suffering From Biliary AtresiaNo drug interventionstreatment1 / 2completed
NCT03112681
Study to Evaluate Safety, Tolerability and Efficacy of Saroglitazar Mg in Patients With Primary Biliary Cholangitistreatment2completed
NCT02955602
Seladelpar (MBX-8025) in Subjects With Primary Biliary Cholangitis (PBC)treatment2completed
NCT01857284
Safety and Efficacy of Tauroursodeoxycholic Acid Versus Ursofalk in the Treatment of Adult Primary Biliary Cirrhosistreatment3completed
NCT02963077
A Safety and Pharmakokinetic Study of A4250 Alone or in Combination With A3384treatment1completed
NCT03668145
Mesenchymal Stem Cell Transplantation for Refractory Primary Biliary CholangitisNo drug interventionstreatmentNot Availableunknown_status
NCT01614405
Highly Active Antiretroviral Therapy for Patients With Primary Biliary CirrhosistreatmentNot Availablecompleted
NCT04956328
Study of Obeticholic Acid(OCA) Combination With Ursodeoxycholic Acid (UDCA) in Patients With Primay Biliary Cirrhosis (PBC)treatment3unknown_status
NCT04751188
A Study to Assess Efficacy and Safety of Bezafibrate in Patients With Primary Biliary Cholangitistreatment3unknown_status
NCT01440309
Efficacy and Safety Study of Allogenic Mesenchymal Stem Cells for Patients With Refractory Primary Biliary Cirrhosistreatment1unknown_status
NCT03082937
An Open Label, Single-dose, Single Period ADME Study of A4250 in Healthy Subjectstreatment1completed
NCT05374200
Mind-body Wellness Intervention in Primary Biliary Cholangitis (PBC)No drug interventionstreatmentNot Availablecompleted
NCT03809559
Repeatability and Reproducibility of Quantitative MRCPNo drug interventionsNot AvailableNot Availablecompleted
NCT03301506
Seladelpar in Subjects With Primary Biliary Cholangitis (PBC)treatment3recruiting
NCT02321306
An Open-label Study to Evaluate the Long-term Safety and Tolerability of LUM001 in Patients With Primary Biliary Cirrhosistreatment2withdrawn
NCT02135536
Phase 2b Study of NGM282 Extended Treatment in Patients With Primary Biliary Cirrhosistreatment2completed
NCT03665519
Clinical Trial on the Effect of the Sublimated Mare Milk Supplement on Primary Biliary CholangitistreatmentNot Availablecompleted
NCT06061341
TruGraf Liver Gene Expression Serial TestNo drug interventionsNot AvailableNot Availableenrolling_by_invitation
NCT01473524
Phase 3 Study of Obeticholic Acid in Patients With Primary Biliary Cirrhosistreatment3completed
NCT01141296
Fenofibrate in Combination With Ursodeoxycholic Acid (UDCA) in Primary Biliary Cirrhosistreatment2withdrawn
NCT02846896
The Health Burden of Primary Biliary Cirrhosis (PBC) in SwitzerlandNo drug interventionsNot AvailableNot Availablecompleted
NCT01904058
Phase 2 Study to Evaluate LUM001 in Combination With Ursodeoxycholic Acid in Patients With Primary Biliary Cirrhosistreatment2completed
NCT01879735
Biliary Excretion of Conjugated Bile Acids in Humans Measured by 11C-cholylsarcosine PET/CTbasic_science1completed
NCT04278820
A Study of TQA3526 in the Treatment of Primary Biliary Cirrhosis (PBC)No drug interventionstreatment2unknown_status
NCT02078882
Study of Abatacept (Orencia) to Treat Primary Biliary Cirrhosistreatment4completed
NCT03253276
Effect of Obeticholic Acid on Transport of Bile Acids in PBC Examined by 11C-cholyl-sarcosine PET/CTbasic_science0completed
NCT06519162
Liver-gut Axis Study Through Identification of Liver Disease-specific MicrobiomeNo drug interventionsNot AvailableNot Availablerecruiting
NCT02477462
Identification of Inflammatory and Fibrotic Biomarkers in PBC and NAFLD PatientsNo drug interventionsNot AvailableNot Availablecompleted
NCT01430429
Primary Biliary Cirrhosis: Investigating A New Treatment Option Using NI-0801, an Anti-CXCL10 Monoclonal AntibodyNo drug interventionsNot Available2terminated
NCT03489889
Development of Ursodeoxycholic Acid 300 mg at Hospital Das Clinicas of the University of São Paulo School of MedicinetreatmentNot Availablecompleted
NCT02026401
Phase 2 Study of NGM282 in Patients With Primary Biliary Cirrhosistreatment2completed
NCT01793168
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at SanfordNo drug interventionsNot AvailableNot Availablerecruiting
NCT01865812
Phase 2 Study on Effects of Obeticholic Acid (OCA) on Lipoprotein Metabolism in Participants With Primary Biliary Cirrhosisbasic_science2completed
NCT02937012
Use of Bezafibrate in Patients With Primary Biliary Cirrhosis to Archive Complete Biochemical Response in Non-responderstreatment3unknown_status
NCT02609048
Study to Evaluate the Effects of Two Doses of MBX-8025 in Subjects With Primary Biliary Cirrhosis (PBC)treatment2terminated
NCT05050136
A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Biliary Cholangitistreatment2recruiting
NCT01654731
Phase 3 Study of Bezafibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cirrhosistreatment3completed
NCT04076527
Prospective, Multicenter Cohort Study on Primary Biliary CholangitisNot AvailableNot Availablerecruiting
NCT06051617
Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated CirrhosisNo drug interventionstreatment3recruiting
NCT06525311
A Study to Evaluate the Pharmacokinetics and Safety of K-808 (Pemafibrate) in Subjects With Primary Biliary Cholangitis With Compensated Cirrhosis and Without Cirrhosis.treatment1recruiting
NCT06060665
IDEAL: Intended to Determine the Effects of Seladelpar on Normalization of Alkaline Phosphatase Levels in Subjects With Primary Biliary Cholangitis (PBC) and an Incomplete Response or Intolerance to Ursodeoxycholic Acid (UDCA)treatment3recruiting
NCT06383403
A Study of Elafibranor in Adults With Primary Biliary Cholangitis and Inadequate Response or Intolerance to Ursodeoxycholic Acid.treatment3recruiting
NCT06488911
To Evaluate Safety and Tolerability of the Fixed- Dose Combination of Obeticholic Acid and BezafibrateNo drug interventionstreatment3enrolling_by_invitation
NCT05190523
Study to Evaluate the Safety and Efficacy of ASC42 Tablets in Subjects With Primary Biliary CholangitisNo drug interventionstreatment2completed
NCT06365424
Fenofibrate in Patients with Primary Biliary Cholangitis (PBC)treatment2 / 3recruiting
NCT06447168
A Study Observing Everyday Effectiveness and Safety of the Drug Elafibranor in Participants With Primary Biliary Cholangitis Who Are Receiving Ongoing TreatmentNo drug interventionsNot AvailableNot Availablerecruiting
NCT04650243
Clinical Research of UCDA Reducing Medication Regimen in Stable PBCtreatment4recruiting
NCT04950764
An Open-Label Study Following Oral Dosing of Seladelpar to Subjects With Primary Biliary Cholangitis (PBC) and Hepatic Impairment (HI)treatment1recruiting
NCT06174402
Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cholangitistreatment2 / 3recruiting
NCT05450887
Efficacy and Safety of Obeticholic Acid in the Treatment of Primary Biliary Cholangitistreatment3completed
NCT04620733
RESPONSE: Response to Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Control to or an Intolerance to Ursodeoxycholic Acid (UDCA)treatment3completed
NCT05104853
Study to Evaluate the Safety, Tolerability, PDs, and Efficacy of CNP-104 in Subjects With Primary Biliary CholangitisNo drug interventionstreatment1 / 2active_not_recruiting
NCT02943447
Study to Evaluate the Safety, Tolerability, and Efficacy of Cilofexor in Adults With Primary Biliary Cholangitis Without Cirrhosistreatment2terminated
NCT02516605
A Multi-part, Double Blind Study to Assess Safety, Tolerability and Efficacy of Tropifexor (LJN452) in PBC Patientstreatment2completed
NCT04376528
Mycophenolate Mofetil Versus Cyclosporin A in the Treatment of Primary Biliary Cholangitis-autoimmune Hepatitis Overlap Syndrome Due to Nonresponse to Standard Therapytreatment4unknown_status
NCT04618575
Ursodeoxycholic Acid Combined With Total Glucosides of Paeony in the Treatment of PBC With AIH Features 1treatment4unknown_status
NCT05133336
Saroglitazar Magnesium for Treatment of Primary Biliary Cholangitistreatment2 / 3active_not_recruiting
NCT06371196
Clinical Study on the Treatment of Elevated Total Bilirubin in Primary Biliary Cholangitis With Baobao Dan CapsuleNo drug interventionstreatment4not_yet_recruiting
NCT05749822
Fenofibrate for Compensated Cirrhosis Patients With Primary Biliary Cholangitistreatment2 / 3recruiting
NCT05786482
Evidence Based Mental Wellness Programming Online for Adults Across Chronic Physical ConditionsNo drug interventionstreatmentNot Availableactive_not_recruiting
NCT03742973
A Study of Baricitinib (LY3009104) in Participants With Primary Biliary Cholangitis Who do Not Respond or Cannot Take UDCAtreatment2terminated
NCT06098027
Study of [14C]CS0159 in China Healthy Subjectsother1completed
NCT03703076
A Post-Authorisation Non-Interventional Observational of Patients in France With Primary Biliary Cholangitis Treated With Obeticholic Acid in Real LifeNo drug interventionsNot AvailableNot Availableunknown_status
NCT06309589
The Effectiveness of Combining Ursodeoxycholic Acid With Vitamin D in Treating Patients With Primary Biliary CholangitistreatmentNot Availablecompleted
NCT05292872
Real-World Data Study to Evaluate the Effectiveness of OCA on Hepatic Outcomes in PBC PatientsNot AvailableNot Availablecompleted
NCT03545672
Early Identification of Myocardial Impairment in PBCNo drug interventionsNot AvailableNot Availablecompleted
NCT05014672
A Trial of Setanaxib in Patients With Primary Biliary Cholangitis (PBC) and Liver Stiffnesstreatment2completed
NCT06427395
Open-Label Extension Study of Saroglitazar Magnesium in Participants with Primary Biliary Cholangitistreatment3recruiting
NCT03322943
The Comparison About the Response of Ursodeoxycholic Acid in Primary Biliary Cholangitis Only and Primary Biliary Cholangitis With High Immune Globulin G or Aminotransferase at West China HospitalNo drug interventionsNot AvailableNot Availablecompleted
NCT03684187
Mindfulness - Based Intervention in the Treatment of Fatigue in Patients With Primary Biliary CholangitisNo drug interventionstreatmentNot Availablesuspended
NCT05919433
Detection Program for Patients With Primary Biliary Cholangitis Lost in the SystemNo drug interventionsNot AvailableNot Availablerecruiting
NCT06417398
Preliminary Clinical Study of UTAA09 Injection in the Treatment of Relapsed/Refractory Autoimmune DiseasesNo drug interventionstreatment0not_yet_recruiting
NCT04617561
Ursodeoxycholic Acid Combined With Low Dose Glucocorticoid in the Treatment of PBC With AIH Features IItreatment4unknown_status
NCT05151809
National Database on Primary Biliary CholangitisNo drug interventionsNot AvailableNot Availablerecruiting
NCT03155932
Safety, Tolerability, and Efficacy of Etrasimod (APD334) in Participants With Primary Biliary Cholangitistreatment2terminated
NCT03394924
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Primary Biliary CholangitisNo drug interventionstreatment2completed
NCT06247735
Study to Evaluate the Efficacy and Safety of K-808 (Pemafibrate) in Participants with Primary Biliary Cholangitis (PBC) with Inadequate Response to Ursodeoxycholic Acid (UDCA) And/or Obeticholic Acid (OCA) Treatment.treatment2recruiting
NCT04265235
EXerCise Intervention in cholesTatic LivEr Disease: The EXCITED StudyNo drug interventionstreatmentNot Availableterminated
NCT02701166
The Effect of Bezafibrate on Cholestatic Itchtreatment3unknown_status
NCT03092765
Study of E6011 in Japanese Subjects With Primary Biliary Cholangitis Inadequately Responding to Ursodeoxycholic AcidNo drug interventionstreatment2terminated
NCT03954327
Combination Antiretroviral Therapy (cART) for PBCtreatment2completed
NCT03602560
ENHANCE: Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)treatment3completed
NCT05624294
Study to Evaluate Safety, Tolerability and Pharmacokinetics of CS0159 in Chinese Healthy Subjectstreatment1completed
NCT04594694
Study of OCA in Combination With BZF Evaluating Efficacy, Safety, and Tolerability in Participants With PBCtreatment2active_not_recruiting
NCT03345589
A Trial of 18-22mg/kg/d Ursodeoxycholic in Refractory Primary Biliary CholangitisNo drug interventionstreatment4unknown_status
NCT05751967
Fenofibrate Combined With Ursodeoxycholic Acid in Subjects With Primary Biliary Cholangitisprevention3recruiting
NCT05239468
Study of OCA in Combination With BZF Evaluating Efficacy, Safety and Tolerability in Participants With PBCtreatment2active_not_recruiting
NCT05293938
A Real-World Data Study to Evaluate the Effectiveness of OCA on Hepatic Outcomes in PBC PatientsNot AvailableNot Availablewithdrawn