Human Recombinant Tissue Non-Specific Alkaline Phosphatase Fusion Protein

( DrugBank: - / KEGG DRUG: - )

1 disease

告示番号	疾患名（ページ内リンク）	臨床試験数
172	低ホスファターゼ症	13

172. 低ホスファターゼ症

臨床試験数 : 34 / 薬物数 : 17 - (DrugBank : 4) / 標的遺伝子数 : 3 - 標的パスウェイ数 : 6

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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	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
2	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
3	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	Phase 2	United States;Taiwan;Saudi Arabia;Spain;Turkey;Russian Federation;United Kingdom;Italy;France;Canada ...
4	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 ...
5	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 ...
6	EUCTR2010-019850-42-DE (EUCTR)	04/03/2011	15/10/2010	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 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	100	Phase 2	United States;Taiwan;Saudi Arabia;Spain;Turkey;Russian Federation;United Kingdom;Italy;France;Canada ...
7	EUCTR2009-009369-32-GB (EUCTR)	30/03/2009	14/04/2009	Extension open-label use of ENB-0040 for infantile hypophosphatasia	Extension Study of ENB-0040 (Human Recombinant Tissue-Nonspecific Alkaline Phosphatase Fusion Protei ...	Infantile hypoposphatasia MedDRA version: 19.1;Level: PT;Classification code 10049933;Term: Hypophos ...	Trade Name: Strensiq Product Name: Asfotase alfa Product Code: Asfotase alfa INN or Proposed INN: Asfot ...	Alexion Pharma GmbH	NULL	Not Recruiting			Female: yes Male: yes	10	Phase 2	United States;United Arab Emirates;United Kingdom
8	EUCTR2008-007406-11-GB (EUCTR)	25/02/2009	15/01/2009	A Multicenter, Open-Label Study of the Safety, Tolerability and Pharmacology of ENB-0040 (Enobia’s h ...	A Multicenter, Open-Label Study of the Safety, Tolerability and Pharmacology of ENB-0040 (Enobia’s h ...	Infantile Hypophosphatasia MedDRA version: 14.1;Level: PT;Classification code 10049933;Term: Hypopho ...	Product Code: ENB-0040 Other descriptive name: Human Recombinant Tissue Non-Specific Alkaline Phospha ...	Enobia Canada Limited Partnership	NULL	Not Recruiting			Female: yes Male: yes	10		United Kingdom
9	NCT00739505 (ClinicalTrials.gov)	August 2008	19/8/2008	Safety Study of Human Recombinant Tissue Non-Specific Alkaline Phosphatase Fusion ProteinAsfotase Al ...	A Multicenter, Open-Label, Dose Escalating Study of the Safety, Tolerability and Pharmacology of Hum ...	Hypophosphatasia (HPP)	Biological: Asfotase Alfa	Alexion Pharmaceuticals	NULL	Completed	18 Years	80 Years	All	6	Phase 1	United States;Canada
10	EUCTR2010-019850-42-FR (EUCTR)		28/09/2015	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: 18.0;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	NA			Female: yes Male: yes	60	Phase 2	United States;Taiwan;Saudi Arabia;Spain;Turkey;United Kingdom;Italy;France;Canada;Argentina;Australi ...

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