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	NCT03633227 (ClinicalTrials.gov)	June 22, 2018	8/4/2018	Study of OCA Evaluating Pharmacokinetics and Safety in Patients With PBC and Hepatic Impairment	A Phase 4, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Pharmacokinetics and Safety of Obeticholic Acid in Patients With Primary Biliary Cholangitis and Moderate to Severe Hepatic Impairment	Liver Cirrhosis, Biliary	Drug: Obeticholic Acid (OCA);Drug: Placebo	Intercept Pharmaceuticals	NULL	Active, not recruiting	18 Years	85 Years	All	50	Phase 4	United States;Argentina;Australia;Belgium;Brazil;Canada;Estonia;Germany;Hungary;Italy;Lithuania;Spain
2	EUCTR2016-002965-67-NL (EUCTR)	07/07/2017	29/03/2017	A study on the effect of obetihcolic acid on bile composition in patients with PBC (chronic liver disease of the small bile ducts), NASH (chronic liver disease as a result of fatty liver) and healthy volunteers	An open, non-randomized, parallel-group pharmokinetic and -dynamic, investigator-initiated study on effects of obeticholic acid (OCA) in bile of patients with primary biliary cholangitis (PBC) and non-alcoholic steatohepatitis (NASH) in comparison to healthy controls - OCABILE	Primary biliairy cholangitis (PBC)Non-alcoholic steatohepatitis (NASH) MedDRA version: 20.0;Level: SOC;Classification code 10019805;Term: Hepatobiliary disorders;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: OCA (INT-747) Product Code: OCA (INT-747)	AMC	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes		Phase 2	Netherlands
3	NCT02308111 (ClinicalTrials.gov)	December 2014	10/11/2014	Phase 4 Study of Obeticholic Acid Evaluating Clinical Outcomes in Patients With Primary Biliary Cholangitis	A Phase 4, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Effect of Obeticholic Acid on Clinical Outcomes in Patients With Primary Biliary Cholangitis	Liver Cirrhosis, Biliary	Drug: Obeticholic Acid (OCA);Drug: Placebo	Intercept Pharmaceuticals	NULL	Recruiting	18 Years	N/A	All	428	Phase 4	United States;Argentina;Australia;Austria;Belgium;Brazil;Bulgaria;Canada;Chile;Denmark;Estonia;Finland;France;Germany;Hong Kong;Hungary;Israel;Italy;Korea, Republic of;Lithuania;Mexico;Netherlands;New Zealand;Poland;Portugal;Serbia;Spain;Sweden;Switzerland;Turkey;United Kingdom;Former Serbia and Montenegro
4	NCT01865812 (ClinicalTrials.gov)	November 2013	23/5/2013	Phase 2 Study on Effects of Obeticholic Acid (OCA) on Lipoprotein Metabolism in Subjects With Primary Biliary Cirrhosis	A Phase 2 Clinical Trial Investigating the Effects of Obeticholic Acid on Lipoprotein Metabolism in Subjects With Primary Biliary Cirrhosis	Primary Biliary Cirrhosis	Drug: obeticholic acid (OCA)	Intercept Pharmaceuticals	NULL	Completed	18 Years	N/A	All	26	Phase 2	United States
5	NCT01473524 (ClinicalTrials.gov)	January 2012	14/11/2011	Phase 3 Study of Obeticholic Acid in Patients With Primary Biliary Cirrhosis	A Phase 3, Double-Blind, Placebo-Controlled Trial and Long-Term Safety Extension of Obeticholic Acid in Patients With Primary Biliary Cirrhosis	Primary Biliary Cirrhosis	Drug: Obeticholic Acid (OCA);Drug: Placebo	Intercept Pharmaceuticals	NULL	Completed	18 Years	N/A	All	217	Phase 3	United States;Australia;Austria;Belgium;Canada;France;Germany;Italy;Netherlands;Poland;Spain;Sweden;United Kingdom

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

NCT03633227
(ClinicalTrials.gov)

June 22, 2018

8/4/2018

Study of OCA Evaluating Pharmacokinetics and Safety in Patients With PBC and Hepatic Impairment

A Phase 4, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Pharmacokinetics and Safety of Obeticholic Acid in Patients With Primary Biliary Cholangitis and Moderate to Severe Hepatic Impairment

Liver Cirrhosis, Biliary

Drug: Obeticholic Acid (OCA);Drug: Placebo

Intercept Pharmaceuticals

NULL

Active, not recruiting

18 Years

85 Years

All

Phase 4

United States;Argentina;Australia;Belgium;Brazil;Canada;Estonia;Germany;Hungary;Italy;Lithuania;Spain

EUCTR2016-002965-67-NL
(EUCTR)

07/07/2017

29/03/2017

A study on the effect of obetihcolic acid on bile composition in patients with PBC (chronic liver disease of the small bile ducts), NASH (chronic liver disease as a result of fatty liver) and healthy volunteers

An open, non-randomized, parallel-group pharmokinetic and -dynamic, investigator-initiated study on effects of obeticholic acid (OCA) in bile of patients with primary biliary cholangitis (PBC) and non-alcoholic steatohepatitis (NASH) in comparison to healthy controls - OCABILE

Primary biliairy cholangitis (PBC)Non-alcoholic steatohepatitis (NASH)
MedDRA version: 20.0;Level: SOC;Classification code 10019805;Term: Hepatobiliary disorders;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: OCA (INT-747)
Product Code: OCA (INT-747)

AMC

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Netherlands

NCT02308111
(ClinicalTrials.gov)

December 2014

10/11/2014

Phase 4 Study of Obeticholic Acid Evaluating Clinical Outcomes in Patients With Primary Biliary Cholangitis

A Phase 4, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Effect of Obeticholic Acid on Clinical Outcomes in Patients With Primary Biliary Cholangitis

Liver Cirrhosis, Biliary

Drug: Obeticholic Acid (OCA);Drug: Placebo

Intercept Pharmaceuticals

NULL

Recruiting

18 Years

N/A

All

428

Phase 4

United States;Argentina;Australia;Austria;Belgium;Brazil;Bulgaria;Canada;Chile;Denmark;Estonia;Finland;France;Germany;Hong Kong;Hungary;Israel;Italy;Korea, Republic of;Lithuania;Mexico;Netherlands;New Zealand;Poland;Portugal;Serbia;Spain;Sweden;Switzerland;Turkey;United Kingdom;Former Serbia and Montenegro

NCT01865812
(ClinicalTrials.gov)

November 2013

23/5/2013

Phase 2 Study on Effects of Obeticholic Acid (OCA) on Lipoprotein Metabolism in Subjects With Primary Biliary Cirrhosis

A Phase 2 Clinical Trial Investigating the Effects of Obeticholic Acid on Lipoprotein Metabolism in Subjects With Primary Biliary Cirrhosis

Primary Biliary Cirrhosis

Drug: obeticholic acid (OCA)

Intercept Pharmaceuticals

NULL

Completed

18 Years

N/A

All

Phase 2

United States

NCT01473524
(ClinicalTrials.gov)

January 2012

14/11/2011

Phase 3 Study of Obeticholic Acid in Patients With Primary Biliary Cirrhosis

A Phase 3, Double-Blind, Placebo-Controlled Trial and Long-Term Safety Extension of Obeticholic Acid in Patients With Primary Biliary Cirrhosis

Primary Biliary Cirrhosis

Drug: Obeticholic Acid (OCA);Drug: Placebo

Intercept Pharmaceuticals

NULL

Completed

18 Years

N/A

All

217

Phase 3

United States;Australia;Austria;Belgium;Canada;France;Germany;Italy;Netherlands;Poland;Spain;Sweden;United Kingdom