297. アラジール症候群 Alagille syndrome Clinical trials / Disease details

臨床試験数 : 45 / 薬物数 : 21 - (DrugBank : 10) / 標的遺伝子数 : 3 - 標的パスウェイ数 : 5

21 trials found

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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	EUCTR2020-004628-40-FR (EUCTR)	25/03/2021	16/12/2020	Clinical study to Evaluate the Safety and Tolerability of Maralixibat in the Treatment of Infants wi ...	Open-Label, Phase 2 Study to Evaluate the Safety and Tolerability of Maralixibat in the Treatment of ...	Cholestatic Liver Diseases Including Progressive Familial Intrahepatic Cholestasis and Alagille Synd ...	Product Name: Maralixibat (formely SHP625 or LUM001) INN or Proposed INN: MARALIXIBAT CHLORIDE Product N ...	Mirum Pharmaceuticals Inc	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	12	Phase 2	France;Poland;Belgium;United Kingdom
2	EUCTR2020-004628-40-BE (EUCTR)	29/01/2021	15/12/2020	Clinical study to Evaluate the Safety and Tolerability of Maralixibat in the Treatment of Infants wi ...	Open-Label, Phase 2 Study to Evaluate the Safety and Tolerability of Maralixibat in the Treatment of ...	Progressive Familial Intrahepatic Cholestasis and Alagille Syndrome MedDRA version: 20.0;Level: PT;C ...	Product Name: Maralixibat (formely SHP625 or LUM001) INN or Proposed INN: MARALIXIBAT CHLORIDE Product N ...	Mirum Pharmaceuticals Inc	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	20	Phase 2	France;United States;Mexico;Poland;Brazil;Belgium;United Kingdom
3	EUCTR2019-002755-42-FR (EUCTR)	24/03/2020	16/01/2020	MERGE: Maralixibat Extension Safety Study Providing Long-term Treatment to Subjects with Cholestatic ...	MRX-800: A Long-Term Safety Study of Maralixibat, an Apical Sodium Dependent Bile Acid Transporter I ...	Long-term safety study with Maralixibat, in treatment of subjects with cholestatic liver disease inc ...	Product Name: Maralixibat (formely SHP625 or LUM001) INN or Proposed INN: MARALIXIBAT CHLORIDE Product N ...	Mirum Pharmaceuticals Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	53	Phase 2	United States;France;Canada;Spain;Poland;Belgium;Australia;United Kingdom
4	EUCTR2019-002755-42-GB (EUCTR)	19/03/2020	23/12/2019	MERGE: Maralixibat Extension Safety Study Providing Long-term Treatment to Subjects with Cholestatic ...	MRX-800: A Long-Term Safety Study of Maralixibat, an Apical Sodium Dependent Bile Acid Transporter I ...	Long-term safety study with Maralixibat, in treatment of subjects with cholestatic liver disease inc ...	Product Name: Maralixibat (formely SHP625 or LUM001) INN or Proposed INN: MARALIXIBAT CHLORIDE Product N ...	Mirum Pharmaceuticals Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	53	Phase 2	United States;France;Canada;Spain;Poland;Belgium;Australia;United Kingdom
5	EUCTR2019-002755-42-ES (EUCTR)	07/02/2020	06/02/2020	MERGE: Maralixibat Extension Safety Study Providing Long-term Treatment to Subjects with Cholestatic ...	MRX-800: A Long-Term Safety Study of Maralixibat, an Apical Sodium Dependent Bile Acid Transporter I ...	Long-term safety study with Maralixibat, in treatment of subjects with cholestatic liver disease inc ...	Product Name: Maralixibat (formely SHP625 or LUM001) INN or Proposed INN: MARALIXIBAT CHLORIDE Product N ...	Mirum Pharmaceuticals Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	53	Phase 2	Canada;Belgium;United States;Poland;United Kingdom;Australia;France;Spain
6	EUCTR2015-000906-20-GB (EUCTR)	13/05/2015	01/04/2015	An Open-label, Multicenter Extension Study to Evaluate the Long-term Safety of LUM001, an Apical Sod ...	An Open-label, Multicenter Extension Study to Evaluate the Long-term Safety of LUM001, an Apical Sod ...	Alagille Syndrome (ALGS) and Progressive Familial Intrahepatic Cholestasis (PFIC) MedDRA version: 17 ...	Product Name: LUM001 Product Code: LUM001 INN or Proposed INN: LUM001	Shire Human Genetic Therapies Inc	NULL	Not Recruiting			Female: yes Male: yes	120	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - ( ...	United States;Canada;Australia;United Kingdom
7	EUCTR2013-005373-43-GB (EUCTR)	21/04/2015	06/02/2015	The purpose of this study is to evaluate a drug (LUM001also known as SHP625) that may help treat the ...	Long-Term, Open-Label Study with a Double-Blind, Placebo Controlled, Randomized Drug Withdrawal Peri ...	Alagille syndrome (ALGS) is an autosomal dominant with variable penetration genetic multisystem diso ...	Product Name: LUM001 Product Code: LUM001 INN or Proposed INN: Maralixibat chloride	Mirum Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	30	Phase 2	France;Belgium;Poland;Spain;Australia;United Kingdom
8	EUCTR2013-005373-43-BE (EUCTR)	18/03/2015	05/02/2015	The purpose of this study is to evaluate a drug (LUM001) that may help treat the liver and control i ...	Long-Term, Open-Label Study with a Double-Blind, Placebo Controlled, Randomized Drug Withdrawal Peri ...	Alagille Syndrome MedDRA version: 18.1;Level: PT;Classification code 10053870;Term: Alagille syndrom ...	Product Name: LUM001 Product Code: LUM001 INN or Proposed INN: LUM001	Lumena Pharmaceuticals LLC	NULL	Not Recruiting			Female: yes Male: yes	30	Phase 2	France;Poland;Spain;Belgium;Australia;United Kingdom
9	NCT02117713 (ClinicalTrials.gov)	March 16, 2015	16/4/2014	An Extension Study to Evaluate the Long-Term Safety and Durability of Effect of LUM001in the Treatme ...	A Multicenter Extension Study to Evaluate the Long-Term Safety and Durability of the Therapeutic Eff ...	Alagille Syndrome	Drug: LUM001 (Maralixibat)	Mirum Pharmaceuticals, Inc.	Lumena Pharmaceuticals, Inc.;Childhood Liver Disease Research and Education Network	Completed	1 Year	18 Years	All	34	Phase 2	United States;Canada
10	NCT02057692 (ClinicalTrials.gov)	November 24, 2014	5/2/2014	Evaluation of LUM001 in the Reduction of Pruritus in Alagille Syndrome	The Evaluation of the Intestinal Bile Acid Transport (IBAT) Inhibitor LUM001in the Reduction of Prur ...	Alagille Syndrome	Drug: LUM001;Drug: Placebo	Mirum Pharmaceuticals, Inc.	Childhood Liver Disease Research and Education Network	Completed	12 Months	18 Years	All	37	Phase 2	United States;Canada

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