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

2 trials found

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 Cholangitis (PSC)	A Phase II, Multicenter, Double-Blind, Randomised, Placebo-Controlled Study and Open-Label Long Term Extension to Evaluate the Safety and Efficacy of Elafibranor in Adult Participants with Primary Sclerosing Cholangitis (PSC)	Adults patients with Primary Sclerosing Cholangitis (PSC) MedDRA version: 20.1;Level: LLT;Classification code 10036732;Term: Primary sclerosing cholangitis;System Organ Class: 100000004871;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]	Product Code: IPN60190; GFT505 INN or Proposed INN: Elafibranor Product Code: IPN60190; GFT505 INN or Proposed INN: Elafibranor	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 Sclerosing Cholangitis.	A Phase II, Multicenter, Double-Blind, Randomised, Placebo-Controlled Study and Open Label Long Term Extension to Evaluate the Safety and Efficacy of Elafibranor in Adult Participants With Primary Sclerosing Cholangitis (PSC).	Primary Sclerosing Cholangitis	Drug: Elafibranor 80 mg;Drug: Elafibranor 120 mg;Drug: Placebo Matched to Elafibranor 80 mg;Drug: Placebo Matched to Elafibranor 120 mg	Ipsen	NULL	Recruiting	18 Years	75 Years	All	60	Phase 2	United States