172. 低ホスファターゼ症 Hypophosphatasia Clinical trials / Disease details

臨床試験数 : 34 / 薬物数 : 19 - (DrugBank : 4) / 標的遺伝子数 : 3 - 標的パスウェイ数 : 6

24 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	NCT02496689 (ClinicalTrials.gov)	May 17, 2016	8/7/2015	Expanded Access Program for Asfotase Alfa Treatment for Patients With Infantile- or Juvenile-onset H ...	An Open-label, Multicenter, Expanded Access Program for Asfotase Alfa (Human Recombinant Tissue-nons ...	Hypophosphatasia	Biological: asfotase alfa	Alexion Pharmaceuticals	NULL	Approved for marketing	N/A	N/A	All			United States;France
2	EUCTR2015-003131-35-DE (EUCTR)	19/04/2016	03/12/2015	A Phase 2a Randomized, Multi-center, Open-Label, Pharmacokinetic, and Dose Response Study of Asfotas ...	A Phase 2a Randomized, Multi-center, Open-Label, Pharmacokinetic, and Dose Response Study of Asfotas ...	Hypophosphatasia is a rare inborn error of bone metabolism caused by inactivating mutations in the g ...	Trade Name: Strensiq Product Name: asfotase alfa INN or Proposed INN: ASFOTASE ALFA Other descriptive n ...	Alexion Pharma GmbH	NULL	Not Recruiting			Female: yes Male: yes	36	Phase 2	United States;Germany
3	EUCTR2015-000809-39-FR (EUCTR)	04/02/2016	05/08/2015	Access Program for Asfotase Alfa	An Open-label, Multicenter, Expanded Access Program for Asfotase Alfa (human recombinant tissue-nons ...	Hypophosphatasia MedDRA version: 18.0;Level: PT;Classification code 10049933;Term: Hypophosphatasia; ...	Trade Name: Strensiq Product Name: Asfotas Alfa Product Code: ENB-0040 INN or Proposed INN: ASFOTASE AL ...	Alexion Pharma International Sàrl	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 4	France;Belgium;Spain;Russian Federation;Netherlands
4	NCT02531867 (ClinicalTrials.gov)	June 2015	11/8/2015	Post-approval Clinical Study of Asfotase Alfa Treatment for Patients With Hypophosphatasia (HPP) in ...	A Multicenter, Post-Approval Clinical Study for Asfotase Alfa (Human Recombinant Tissue-nonspecific ...	Hypophosphatasia	Biological: Asfotase Alfa	Alexion Pharmaceuticals	NULL	Completed	N/A	N/A	All	13	Phase 4	NULL
5	JPRN-UMIN000014816	2014/08/11	11/08/2014	A Multicenter study of the safety and efficacy of Asfotase Alfa (ALXN1215) (Human Recombinant Tissue ...		hypophosphatasia	Drug: Asfotase Alfa (ALXN1215) Dose: 6mg/kg/week (divided 3 times a week)	HPP study group	Translational Research Informatics Center	Complete: follow-up complete	Not applicable	Not applicable	Male and Female	20	Not selected	Japan
6	NCT02456038 (ClinicalTrials.gov)	August 2014	26/3/2015	Safety and Efficacy of Asfotase Alfa in Patients With Hypophosphatasia (HPP)	A Multicenter Study of the Safety and Efficacy of Asfotase Alfa (ALXN1215) (Human Recombinant Tissue ...	Hypophosphatasia	Drug: Asfotase Alfa (ALXN1215)	Translational Research Informatics Center, Kobe, Hyogo, Japan	Osaka University Graduate School of Medicine	Completed	N/A	N/A	Both	13	Phase 2	Japan
7	EUCTR2010-019850-42-GB (EUCTR)	05/09/2013	01/02/2013	An Open-Label, Multicenter, Multinational Study of the Safety, Efficacy and Pharmacokinetics of Asfo ...	An Open-Label, Multicenter, Multinational Study of the Safety, Efficacy and Pharmacokinetics of Asfo ...	Hypophosphatasia MedDRA version: 19.1;Level: PT;Classification code 10049933;Term: Hypophosphatasia; ...	Trade Name: Strensiq Product Name: Asfotase alfa INN or Proposed INN: Asfotase alfa Other descriptive n ...	Alexion Pharma GmbH	NULL	Not Recruiting			Female: yes Male: yes	100	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - ( ...	United States;Taiwan;Saudi Arabia;Spain;Turkey;Russian Federation;United Kingdom;Italy;France;Canada ...
8	EUCTR2010-019850-42-ES (EUCTR)	28/06/2013	09/04/2013	An Open-Label, Multicenter, Multinational Study of the Safety, Efficacy and Pharmacokinetics of Asfo ...	An Open-Label, Multicenter, Multinational Study of the Safety, Efficacy and Pharmacokinetics of Asfo ...	Hypophosphatasia MedDRA version: 14.1;Level: PT;Classification code 10049933;Term: Hypophosphatasia; ...	Product Name: Asfotase alfa Product Code: ENB-0040 INN or Proposed INN: Asfotase alfa Other descriptive ...	Alexion Pharma International Sàrl	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 2	United States;Saudi Arabia;Taiwan;Spain;Turkey;United Kingdom;Italy;France;Canada;Argentina;Australi ...
9	EUCTR2010-019850-42-IT (EUCTR)	09/05/2013	01/03/2013	An Open-Label, Multicenter, Multinational Study of the Safety, Efficacy and Pharmacokinetics of Asfo ...	An Open-Label, Multicenter, Multinational Study of the Safety, Efficacy and Pharmacokinetics of Asfo ...	Hypophosphatasia MedDRA version: 15.1;Level: PT;Classification code 10049933;Term: Hypophosphatasia; ...	Product Name: Asfotase alfa Product Code: ENB-0040 INN or Proposed INN: Asfotase alfa Other descriptive ...	Alexion Pharma International Sàrl	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 2	United States;Saudi Arabia;Taiwan;Spain;Turkey;Italy;United Kingdom;France;Canada;Argentina;Australi ...
10	EUCTR2010-024013-31-DE (EUCTR)	30/06/2011	07/02/2011	A clinical study to evaluate the safety and preliminary efficacy of BPS804 in adults with hypophosph ...	An open-label, intra-patient dose-escalation study to evaluate the safety and tolerability, pharmaco ...	Hypophosphatasia (HPP) is a rare genetic metabolic disorder which results in impaired skeletal miner ...	Product Name: BPS804 Product Code: BPS804 Other descriptive name: fully human IgG2 lambda monoclonal a ...	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	9		Germany

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