94. 原発性硬化性胆管炎 Primary sclerosing cholangitis Clinical trials / Disease details

臨床試験数 : 142 / 薬物数 : 113 - (DrugBank : 37) / 標的遺伝子数 : 19 - 標的パスウェイ数 : 139

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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	EUCTR2019-002945-39-ES (EUCTR)	20/01/2022	19/10/2021	A study to look at how well study drug CM-101 works in people with disease of the liver and gallblad ...	A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Clinical Trial Evaluating the Safety and E ...	Primary Sclerosing Cholangitis MedDRA version: 20.1;Level: LLT;Classification code 10036732;Term: Pr ...	Product Name: CM-101 Product Code: CM-101 INN or Proposed INN: TBC Other descriptive name: Humanised Ig ...	ChemomAb Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	45	Phase 2	Spain;Israel;United Kingdom
2	EUCTR2020-003027-41-DE (EUCTR)	17/11/2021	17/06/2021	A study to evaluate efficacy and safety of an investigational drug named volixibat in patients with ...	A Randomized Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of Volixibat ...	Pruritus associated with Primary Sclerosing Cholangitis(PSC) MedDRA version: 20.1;Level: LLT;Classif ...	Product Name: Volixibat (formely SHP626, LUM002 or SAR548304B) INN or Proposed INN: Volixibat potassium ...	Mirum Pharmaceuticals, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	200	Phase 2	United States;Canada;Israel;Germany;United Kingdom
3	NCT05082779 (ClinicalTrials.gov)	October 26, 2021	25/9/2021	Study in Healthy Volunteers to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynam ...	A Phase I, Randomized, Double-Blind, Placebo-Contralled, Single Asending Dose / Multiple Ascending D ...	Primary Sclerosing Cholangitis (PSC)	Drug: CS0159	Cascade Pharmaceuticals, Inc	Covance	Recruiting	18 Years	55 Years	All	80	Phase 1	United States
4	EUCTR2020-001428-33-NL (EUCTR)	27/07/2021	31/08/2020	A study to assess efficacy, safety and pharmacokinetics of PLN-74809 in participants with primary sc ...	A randomized, double-blind, dose-ranging, placebo-controlled, Phase 2a evaluation of the safety, tol ...	Primary sclerosing cholangitis(PSC) MedDRA version: 20.1;Level: LLT;Classification code 10036732;Ter ...	Product Name: PLN-74809 Product Code: PLN-74809 INN or Proposed INN: Not yet established	Pliant Therapeutics, Inc	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	84	Phase 2	France;United States;Canada;Belgium;Austria;Australia;Norway;Germany;Netherlands;United Kingdom
5	NCT04309773 (ClinicalTrials.gov)	April 6, 2021	18/10/2019	Efficacy of 24 Month of Bezafibrate in Primary Sclerosing CholangitisWith Persistent Cholestasis Des ...	Double Blind, Multicentric, Randomized, Placebo-controlled Trial, Evaluating the Efficacy of 24 Mont ...	Primary Sclerosing Cholangitis;Cholestasis	Drug: Bezafibrate (400mg) in addition to standard 15-20 mg/kg/jour UDCA therapy;Drug: Placebo of Beza ...	Assistance Publique - Hôpitaux de Paris	NULL	Recruiting	18 Years	75 Years	All	104	Phase 3	France
6	NCT03678480 (ClinicalTrials.gov)	March 1, 2021	18/9/2018	A Study of HTD1801 in Adolescents With Primary Sclerosing Cholangitis (PSC)	A Phase 2, Randomized, Double-Blind Study of HTD1801 vs Ursodeoxycholic Acid (UDCA) in Adolescents W ...	Primary Sclerosing Cholangitis;Cholangitis;Cholangitis, Sclerosing;Bile Duct Diseases;Biliary Tract ...	Drug: HTD1801;Drug: Ursodeoxycholic Acid	HighTide Biopharma Pty Ltd	NULL	Withdrawn	12 Years	17 Years	All	0	Phase 2	NULL
7	EUCTR2020-001428-33-DE (EUCTR)	15/02/2021	17/07/2020	A study to assess efficacy, safety and pharmacokinetics of PLN-74809 in participants with primary sc ...	A randomized, double-blind, dose-ranging, placebo-controlled, Phase 2a evaluation of the safety, tol ...	Primary sclerosing cholangitis(PSC) MedDRA version: 20.1;Level: LLT;Classification code 10036732;Ter ...	Product Name: PLN-74809 Product Code: PLN-74809 INN or Proposed INN: Not yet established Product Name: ...	Pliant Therapeutics, Inc	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	112	Phase 2	France;United States;Canada;Belgium;Austria;Australia;Netherlands;Germany;United Kingdom
8	NCT04663308 (ClinicalTrials.gov)	December 18, 2020	17/11/2020	A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With ...	A Randomized Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of Volixibat ...	Primary Sclerosing Cholangitis	Drug: Volixibat;Drug: Placebo	Mirum Pharmaceuticals, Inc.	NULL	Recruiting	18 Years	N/A	All	200	Phase 2	United States
9	EUCTR2020-001428-33-GB (EUCTR)	05/11/2020	22/06/2020	A study to assess efficacy, safety and pharmacokinetics of PLN-74809 in participants with primary sc ...	A randomized, double-blind, dose-ranging, placebo-controlled, Phase 2a evaluation of the safety, tol ...	Primary sclerosing cholangitis(PSC) MedDRA version: 20.1;Level: LLT;Classification code 10036732;Ter ...	Product Name: PLN-74809 Product Code: PLN-74809 INN or Proposed INN: Not yet established	Pliant Therapeutics, Inc	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	84	Phase 2	United States;France;Canada;Belgium;Austria;Australia;Norway;Netherlands;Germany;United Kingdom
10	NCT04595825 (ClinicalTrials.gov)	October 1, 2020	7/10/2020	CM-101 in PSC Patients -The SPRING Study	A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Clinical Trial Evaluating The Safety And E ...	Primary Sclerosing Cholangitis	Biological: CM-101;Other: Placebo	ChemomAb Ltd.	NULL	Recruiting	18 Years	75 Years	All	45	Phase 2	Germany;Israel;United Kingdom

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