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

臨床試験数 : 148 / 薬物数 : 118 - (DrugBank : 39) / 標的遺伝子数 : 18 - 標的パスウェイ数 : 141

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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	EUCTR2022-002695-37-ES (EUCTR)	13/02/2023	10/01/2023	A study on safety and efficacy of Elafibranor in Adult Participants with Primary Sclerosing Cholangi ...	A Phase II, Multicenter, Double-Blind, Randomised, Placebo-Controlled Study and Open-Label Long Term ...	Adults patients with Primary Sclerosing Cholangitis(PSC) MedDRA version: 20.1;Level: LLT;Classificat ...	Product Code: IPN60190; GFT505 INN or Proposed INN: Elafibranor Product Code: IPN60190; GFT505 INN or P ...	Ipsen Bioscience, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	60	Phase 2	Canada;United States;Italy;United Kingdom;France;Portugal;Germany;Spain
2	NCT05627362 (ClinicalTrials.gov)	January 27, 2023	22/11/2022	A Study to Assess Safety and Effectiveness of Elafibranor in Adult Participants With Primary Scleros ...	A Phase II, Multicenter, Double-Blind, Randomised, Placebo-Controlled Study and Open Label Long Term ...	Primary Sclerosing Cholangitis	Drug: Elafibranor 80 mg;Drug: Elafibranor 120 mg;Drug: Placebo Matched to Elafibranor 80 mg;Drug: Place ...	Ipsen	NULL	Recruiting	18 Years	75 Years	All	60	Phase 2	United States
3	NCT05642468 (ClinicalTrials.gov)	January 23, 2023	23/11/2022	Safety and Tolerability of A3907 in Primary Sclerosing Cholangitis	An Open Label, Phase 2 Study to Evaluate the Effect of A3907 on Safety, Tolerability, Pharmacokineti ...	Primary Sclerosing Cholangitis	Drug: A3907	Albireo	NULL	Recruiting	18 Years	65 Years	All	12	Phase 2	France;Italy;Spain
4	NCT05295680 (ClinicalTrials.gov)	November 2022	4/3/2022	Oral Hymecromone to Treat Adolescents and Adults With Primary Sclerosing Cholangitis.	A Study of Oral Hymecromone to Treat Adolescents and Adults With Primary Sclerosing Cholangitis(HAAP ...	Primary Sclerosing Cholangitis	Drug: Hymecromone	Paul Bollyky	NULL	Not yet recruiting	14 Years	75 Years	All	24	Phase 2	United States
5	NCT05525520 (ClinicalTrials.gov)	October 6, 2022	30/8/2022	Study to Evaluate EP547 in Subjects With Cholestatic Pruritus Due to Primary Biliary Cholangitis or ...	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
6	NCT05376228 (ClinicalTrials.gov)	February 1, 2022	11/5/2022	A Systems Biology Approach for Identification of Host and Microbial Mechanisms and Druggable Targets ...	A Systems Biology Approach for Identification of Host and Microbial Mechanisms and Druggable Targets ...	Inflammatory Bowel Diseases;Primary Sclerosing Cholangitis	Drug: Oral Vancomycin	University Hospital Birmingham NHS Foundation Trust	NULL	Recruiting	18 Years	N/A	All	15		United Kingdom
7	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
8	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	300	Phase 2	United States;Canada;Israel;Germany;United Kingdom
9	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	Completed	18 Years	55 Years	All	79	Phase 1	United States
10	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 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;Germany;Netherlands;United Kingdom

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