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	NCT02963077 (ClinicalTrials.gov)	July 2013	1/11/2016	A Safety and Pharmakokinetic Study of A4250 Alone or in Combination With A3384	A Phase I, Double-Blind Single and Multiple Ascending Dose Study to Assess Safety and Pharmacokinetics of A4250 as Monotherapy, and in Combination With Colonic Release Cholestyramine (A3384) or Commercially Available Cholestyramine (Questran™) in Healthy Subjects	Orphan Cholestatic Liver Diseases;Primary Biliary Cirrhosis;Progressive Familial Intrahepatic Cholestasis;Alagille Syndrome	Drug: A4250;Drug: CRC (A3384);Drug: Questran;Drug: Placebo	Albireo	NULL	Completed	18 Years	60 Years	Both	94	Phase 1	NULL

No.

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agemin

Inclusion_
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NCT02963077
(ClinicalTrials.gov)

July 2013

1/11/2016

A Safety and Pharmakokinetic Study of A4250 Alone or in Combination With A3384

A Phase I, Double-Blind Single and Multiple Ascending Dose Study to Assess Safety and Pharmacokinetics of A4250 as Monotherapy, and in Combination With Colonic Release Cholestyramine (A3384) or Commercially Available Cholestyramine (Questran™) in Healthy Subjects

Orphan Cholestatic Liver Diseases;Primary Biliary Cirrhosis;Progressive Familial Intrahepatic Cholestasis;Alagille Syndrome

Drug: A4250;Drug: CRC (A3384);Drug: Questran;Drug: Placebo

Albireo

NULL

Completed

18 Years

60 Years

Both

Phase 1

NULL