DDrare: Database of Drug Development for Rare Diseases

Searched query = "Primary biliary cholangitis", "Primary biliary cirrhosis", "PBC"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Drug = 1-20190; 11C-CSar; 13-15mg/kg/d Ursodeoxycholic; 18-22mg/kg/d Ursodeoxycholic; 3 mg [14C]-A4250 capsule; 3a,7a-dihydroxy-6a-ethyl-5betacholan-24-oic acid; 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-oic acid; 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747; 6 alpha-ethylchenodeoxycholic acid (6-EDCA), oCA, INT-747; 6-ECDCA; 6-ethylchenodeoxycholic acid; 6?-ethylchenodeoxycholic acid (6-ECDCA), OCA, INT-747; 6?-ethylchenodeoxycholic acid (6-ECDCA), OCA, Int-747; 6a-ethylchenodeoxycholic acid (6-ECDCA), OCA, INT-747; 6a-ethylchenodeoxycholic acid (6-ECDCA), OCA, Int-747; 6a-ethylchenodeoxycholic acid , 6-ethylchenodeoxycholic acid; 6a-ethylchenodeoxycholic acid , 6-ethylchenodeoxycholic acid, 3a,7a-dihydroxy-6a-ethyl-5betacholan-24-o; 6a-ethylchenodeoxycholic acid , 6-ethylchenodeoxycholic acid, 3a,7a-dihydroxy-6a-ethyl-5betacholan-24-o, obeticholic acid (OCA); 6a-ethylchenodeoxycholic acid , 6-ethylchenodeoxycholic acid, 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-o; 6a-ethylchenodeoxycholic acid , 6-ethylchenodeoxycholic acid, 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-o, obeticholic acid (OCA); 6a-ethylchenodeoxycholic acid, 6-ethylchenodeoxycholic acid; 6a-ethylchenodeoxycholic acid, 6-ethylchenodeoxycholic acid, 3a,7a-dihydroxy-6a-ethyl-5betacholan-24-o; 6a-ethylchenodeoxycholic acid, 6-ethylchenodeoxycholic acid, 3a,7a-dihydroxy-6a-ethyl-5betacholan-24-o , obeticholic acid (OCA); 6a-ethylchenodeoxycholic acid, 6-ethylchenodeoxycholic acid, 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-o; 6a-ethylchenodeoxycholic acid, 6-ethylchenodeoxycholic acid, 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-o , obeticholic acid (OCA); A11HA02; A4250; APD334; Abatacept; Acido Obeticolico; Acido ursodessicolico; Alkaline Phosphatase; Atorvastatin; BARICITINIB; BCD-085; BEZAFIBRATE; BUDESONIDE; Baricitinib; Bezafibrat; Bezafibrat Genericon retard 400 mg; Bezafibrate; Bezafibrate 200 MG; Bezafibrate 400 MG; Bezafibrate IR; Bezafibrate SR; Bezafibrate, Beza, BZF, Bezalip; Bezafibrate, Beza, BZF, Bezalip mono; Bezalip; Bezalip mono; Biological: mesenchymal stem cell; Budenofalk 3mg; Budesonide; CNTO1275; CR845 1.0 mg; CRC (A3384); Calcium; Choline; Cilofexor; Colchicine; Combination antiviral therapy; Cyclophosphamide; Cyclosporin; Cyclosporin A; Denosumab; Device: Fibroscan; E6011; EDP-305; EDP-305 Dose 1; EDP-305 Dose 2; ELAFIBRANOR; EZETIMIBE; EZT; Elafibranor; Elafibranor 120 mg; Elafibranor 80 mg; Elafibranor 80mg; Emtricitabine; Emtricitabine (FTC)/Tenofovir Disoproxil (TDF); Experimental: Seladelpar / MBX-8025 200 mg; Experimental: Seladelpar / MBX-8025 50 mg; Ezetimibe; Ezetrol; FFP104; Fenofibrate; Fenofibrate IDD-P (Insoluble Drug Delivery-Micro Particle); Fully human monoclonal antibody directed against CXCL10; Fuzhenghuayu; GFT505; GKT137831; GS-9674; GS-9674 100 mg; GS-9674 30 mg; GSK2330672; Gold; HTD1801 (BUDCA); High protein high fiber diet; ICG; INT-747; INT-747, OCA; Kaletra; LJN452; LJN452, 0,01 mg; LJN452, 0,03 mg; LJN452, 0,1 mg; LUM001; LY3009104; Linerixibat; Linerixibat (GSK2330672) 45mg; Liver biopsy; MBX 8025; MBX-8025; MBX-8025 10 mg Capsule; MBX-8025 2 mg Capsule; MBX-8025 5 mg Capsule; MBX-8025, DSIC; MBX-8025, Formulation 2; MabThera; MabThera®; Magnesium; Methionine; Methotrexate; Minodronic acid; Modafinil; Moexipril; Mycophenolate; Mycophenolate Mofetil; Mycophenolate mofetil; NGM282; NI-0801; Non-myeloablative Hematopoietic Stem Cell Transplantation; OCA (INT-747); OCA, INT-747; OP-724; Obeticholic Acid; Obeticholic Acid (OCA); Obeticholic acid; Obeticholic acid (OCA); Ocaliva; Ocaliva 10mg; Ocaliva 5mg; Olumiant; Other: Blood samples; Other: Questionnaires; PYRIDOXINE; Part 1: LJN452; Part 2: LJN452 Dose level 1; Part 2: LJN452 Dose level 2; Pemafibrate; Pentoxifylline; Phenylbutyrate; Prednisone; Probiotic; Pyridoxine; Pyridoxine 10mg; Pyridoxine 10mg BP; Questran; Raltegravir; RhuDex 100 mg (127 mg RhuDex choline salt) granules; RhuDex 25 mg (31.75 mg RhuDex choline salt) granules; RhuDex 50 mg (63.5 mg RhuDex choline salt) granules; RhuDex choline salt; Rifampicin; Risedronic acid; Rituximab; S-adenosyl-L-methionine; S-adenosyl-methionine (SAMe) capsules; SAMe; SELADELPAR; Saroglitazar; Saroglitazar magnesium 2 mg; Saroglitazar magnesium 4 mg; Seladelpar; Seladelpar 10 mg; Seladelpar 10 mg Capsule; Seladelpar 5 mg; Seladelpar 5 mg Capsule; Seladelpar 5-10 mg; Sortis; Sortis 10 mg; Sublimated mare milk; TQA3526; Tauroursodeoxycholic Acid Capsules; Tauroursodeoxycholic acid; Tenofovir; Tenofovir disoproxil; Tetrathiomolybdate; Tigecycline; Tropifexor; Truvada and Kaletra; UDCA; UDCA (Ursodeoxycholic acid); URSODEOXYCHOLIC ACID; Umbilical Cord Derived Mesenchymal Stem Cell (UC -MSC) Transplantation; Ursodeoxycholic Acid; Ursodeoxycholic Acid (URSO); Ursodeoxycholic Acid 300mg capsule; Ursodeoxycholic Acid 300mg tablet; Ursodeoxycholic Acid Capsules; Ursodeoxycholic acid; Ursodeoxycholic acid combination of immunosuppressive agents; Ursodeoxycholic acid combined with total glucosides of paeony; Ursodeoxycholic acid only; Ursodeoxycholic acid+Low Dose Glucocorticoid(prednisone); Ursodeoxycholsäure; Ursodiol; Ursofalk; Ursofalk® 500 mg Filmtabletten; Ursofalk® 500 mg film-coated tablets; Ursofalk® capsules; Ustekinumab; Ustekinumab 180 mg; Ustekinumab 45 mg; Ustekinumab 90 mg; Vitamin D; Zoledronic acid

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT04526665 (ClinicalTrials.gov)	September 24, 2020	21/8/2020	Study of Elafibranor in Patients With Primary Biliary Cholangitis (PBC)	A Double-blind, Randomized, Placebo-Controlled Study and Open-label Long Term Extension to Evaluate the Efficacy and Safety of Elafibranor 80 mg in Patients With Primary Biliary Cholangitis With Inadequate Response or Intolerance to Ursodeoxycholic Acid	Primary Biliary Cirrhosis	Drug: Elafibranor 80mg;Drug: Placebo	Genfit	NULL	Recruiting	18 Years	75 Years	All	150	Phase 3	United States

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NCT04526665
(ClinicalTrials.gov)

September 24, 2020

21/8/2020

Study of Elafibranor in Patients With Primary Biliary Cholangitis (PBC)

A Double-blind, Randomized, Placebo-Controlled Study and Open-label Long Term Extension to Evaluate the Efficacy and Safety of Elafibranor 80 mg in Patients With Primary Biliary Cholangitis With Inadequate Response or Intolerance to Ursodeoxycholic Acid

Primary Biliary Cirrhosis

Drug: Elafibranor 80mg;Drug: Placebo

Genfit

NULL

Recruiting

18 Years

75 Years

All

150

Phase 3

United States