ASFOTASE ALFA ( DrugBank: Asfotase alfa )

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	26

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	NCT05234567 (ClinicalTrials.gov)	March 17, 2022	1/2/2022	A Prospective Sub-Study of the Global Hypophosphatasia Registry	A Prospective Observational Sub-Study of the Global Hypophosphatasia Registry to Describe the Potent ...	Hypophosphatasia	Biological: Asfotase Alfa	Alexion Pharmaceuticals	NULL	Recruiting	N/A	N/A	All	40		United States
2	NCT04189315 (ClinicalTrials.gov)	April 2020	4/12/2019	Relieving Burden of Hypophosphatasia in Adults With Functional Impairment Due to Chronic Disease	A Phase 4, Randomized, Multicenter, Open-Label, 2-Dosage Regimen, Safety and Tolerability, Efficacy, ...	Hypophosphatasia	Drug: asfotase alfa	Alexion Pharmaceuticals	NULL	Withdrawn	18 Years	N/A	All	0	Phase 4	NULL
3	NCT04195763 (ClinicalTrials.gov)	November 6, 2019	10/12/2019	Patient Reported Outcomes in Adults With Pediatric-onset Hypophosphatasia Treated With Strensiq® (As ...	A Prospective Study to Evaluate the Patient Reported Quality of Life Prior to and After Strensiq® Tr ...	Hypophosphatasia	Drug: asfotase alfa	Alexion	Xcenda, LLC	Active, not recruiting	18 Years	99 Years	All	100		United States
4	NCT02797821 (ClinicalTrials.gov)	June 6, 2016	23/5/2016	Pharmacokinetic and Dose Response Study of Asfotase Alfain Adult Patients With Pediatric-Onset Hypop ...	A Phase 2a, Randomized, Multicenter, Open-Label, Pharmacokinetic, and Dose Response Study of Asfotas ...	Hypophosphatasia	Drug: Asfotase alfa	Alexion Pharmaceuticals	NULL	Completed	18 Years	N/A	All	27	Phase 2	United States;Germany
5	NCT02496689 (ClinicalTrials.gov)	May 17, 2016	8/7/2015	Expanded Access Program for Asfotase AlfaTreatment for Patients With Infantile- or Juvenile-onset Hy ...	An Open-label, Multicenter, Expanded Access Program for Asfotase Alfa(Human Recombinant Tissue-nonsp ...	Hypophosphatasia	Biological: asfotase alfa	Alexion Pharmaceuticals	NULL	Approved for marketing	N/A	N/A	All			United States;France
6	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
7	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-nonsp ...	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
8	NCT02531867 (ClinicalTrials.gov)	June 2015	11/8/2015	Post-approval Clinical Study of Asfotase AlfaTreatment for Patients With Hypophosphatasia (HPP) in J ...	A Multicenter, Post-Approval Clinical Study for Asfotase Alfa(Human Recombinant Tissue-nonspecific A ...	Hypophosphatasia	Biological: Asfotase Alfa	Alexion Pharmaceuticals	NULL	Completed	N/A	N/A	All	13	Phase 4	NULL
9	JPRN-UMIN000014816	2014/08/11	11/08/2014	A Multicenter study of the safety and efficacy of Asfotase Alfa(ALXN1215) (Human Recombinant Tissue ...	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
10	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

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