93. 原発性胆汁性胆管炎 Primary biliary cholangitis Clinical trials / Disease details

臨床試験数 : 298 / 薬物数 : 252 - (DrugBank : 59) / 標的遺伝子数 : 35 - 標的パスウェイ数 : 115

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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	NCT05751967 (ClinicalTrials.gov)	February 22, 2023	13/12/2022	Fenofibrate Combined With Ursodeoxycholic Acid in Subjects With Primary Biliary Cholangitis	A Prospective, Multi-center, Randomized, Double-blind, Placebo-controlled Study: Fenofibrate Combine ...	Primary Biliary Cholangitis	Drug: Placebo Combined With Ursodeoxycholic Acid;Drug: Fenofibrate Combined With Ursodeoxycholic Acid ...	Xijing Hospital of Digestive Diseases	NULL	Recruiting	18 Years	75 Years	All	150	Phase 3	China
2	NCT05749822 (ClinicalTrials.gov)	February 17, 2023	29/12/2022	Fenofibrate for Compensated Cirrhosis Patients With Primary Biliary Cholangitis	Fenofibrate Combined With Ursodeoxycholic Acid in Compensated Cirrhosis Patients With Primary Biliar ...	Primary Biliary Cholangitis	Drug: Fenofibrate 200mg;Drug: Placebo;Drug: UDCA	Xijing Hospital of Digestive Diseases	NULL	Recruiting	18 Years	75 Years	All	104	Phase 2/Phase 3	China
3	EUCTR2022-001634-10-ES (EUCTR)	23/01/2023	13/10/2022	Study to Evaluate Safety, Tolerability and Efficacy in patients with Primary Biliary Cholangitisof S ...	A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2b/3 Study to Evaluate the Effica ...	Primary biliary Cholangitis MedDRA version: 21.0;Level: PT;Classification code 10080429;Term: Primar ...	Product Name: Saroglitazar Magnesium 1 mg INN or Proposed INN: SAROGLITAZAR MAGNESIUM Other descriptive n ...	Zydus Therapeutics Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	192	Phase 2;Phase 3	United States;Argentina;Spain;Turkey;Iceland;Colombia;United Kingdom;Italy
4	NCT05624294 (ClinicalTrials.gov)	December 19, 2022	14/11/2022	Study to Evaluate Safety, Tolerability and Pharmacokinetics of CS0159 in Chinese Healthy Subjects	A Phase I, Randomized, Double-blind, Placebo-controlled, Single Ascending Does/ Mulelple Ascending D ...	Primary Biliary Cholangitis	Drug: CS0159;Drug: Placebo	Cascade Pharmaceuticals, Inc	NULL	Recruiting	18 Years	55 Years	All	36	Phase 1	China
5	EUCTR2019-003158-10-GR (EUCTR)	19/12/2022	25/10/2022	Linerixibat Long-term Safety and Tolerability Study (LLSAT)	Long-term Safety and Tolerability Study of Linerixibat for the Treatment of Cholestatic Pruritus in ...	Moderate to Severe Pruritus (itching) caused by primary biliary cholangitis(PBC) MedDRA version: 24. ...	Product Name: linerixibat (GSK2330672) 40 mg Product Code: GSK2330672 INN or Proposed INN: Linerixibat	GlaxoSmithKline Research & Development Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	305	Phase 3	United States;Czechia;Greece;Israel;Russian Federation;Italy;United Kingdom;Switzerland;France;Mexic ...
6	NCT05525520 (ClinicalTrials.gov)	October 6, 2022	30/8/2022	Study to Evaluate EP547 in Subjects With Cholestatic Pruritus Due to Primary Biliary Cholangitisor P ...	Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of EP547 in Subjects With ...	Pruritus	Drug: EP547;Drug: Placebo	Escient Pharmaceuticals, Inc	NULL	Recruiting	18 Years	80 Years	All	58	Phase 2	United States
7	EUCTR2022-000422-16-HU (EUCTR)	26/07/2022	24/05/2022	A two-part study to investigate the effects in adults of two doses of a new drug called golexanolone ...	A randomised, double-blind, placebo-controlled, two-part study to evaluate the pharmacokinetics, saf ...	Primary biliary cholangitis(PBC) MedDRA version: 20.0;Level: SOC;Classification code 10019805;Term: ...	Product Name: Golexanolone Product Code: GR3027 INN or Proposed INN: GOLEXANOLONE	Umecrine Cognition AB	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	101	Phase 1;Phase 2	Serbia;Hungary;Germany;United Kingdom;Italy
8	EUCTR2021-000007-21-GR (EUCTR)	28/06/2022	11/05/2022	Global Linerixibat Itch STudy of Efficacy and Safety iN PBC (GLISTEN)	A two-part, randomized, placebo controlled, double blind, multicenter, Phase 3 study to evaluate the ...	Moderate to severe Cholestatic pruritus with primary biliary cholangitis(PBC). MedDRA version: 24.1; ...	Product Name: GSK2330672 /linerixibat 40 mg Product Code: GSK2330672 /linerixibat 40 mg INN or Proposed ...	GlaxoSmithKline Research & Development Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	230	Phase 3	United States;Czechia;Greece;Russian Federation;Israel;United Kingdom;Italy;Switzerland;France;Mexic ...
9	EUCTR2021-000007-21-CZ (EUCTR)	23/06/2022	12/04/2022	Global Linerixibat Itch STudy of Efficacy and Safety iN PBC (GLISTEN)	A two-part, randomized, placebo controlled, double blind, multicenter, Phase 3 study to evaluate the ...	Moderate to severe Cholestatic pruritus with primary biliary cholangitis(PBC). MedDRA version: 24.1; ...	Product Name: GSK2330672 /linerixibat 40 mg Product Code: GSK2330672 /linerixibat 40 mg INN or Proposed ...	GlaxoSmithKline Research & Development Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	230	Phase 3	United States;Czechia;Greece;Israel;Russian Federation;Switzerland;United Kingdom;Italy;France;Czech ...
10	EUCTR2021-001431-56-FI (EUCTR)	04/05/2022	10/03/2022	Clinical study comparing two doses of norucholic acid against placebo in the treatment of a liver di ...	Double-blind, randomised, placebo-controlled, phase II dose-finding study comparing different doses ...	primary biliary cholangitis MedDRA version: 21.0;Level: PT;Classification code 10080429;Term: Primar ...	Product Name: Norucholic acid (NCA) 500 mg Product Code: NCA 500mg INN or Proposed INN: Norucholic acid ...	Dr. Falk Pharma GmbH	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	90	Phase 2	France;Finland;Poland;Belgium;Denmark;Austria;Norway;Netherlands;Germany;United Kingdom;Switzerland

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