DDrare: Database of Drug Development for Rare Diseases

Searched query = "Hypophosphatasia"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Drug = ASFOTASE ALFA; Alkaline Phosphatase; Asfotas Alfa; Asfotase Alfa; Asfotase Alfa (ALXN1215); Asfotase alfa; BPS804; Biochemical analysis of different bone markers.; Cyclophosphamide; ENB-0040; Fully human IgG2 lambda monoclonal antibody; Human Recombinant Tissue Non-Specific Alkaline Phosphatase Fusion Protein; Human recombinant tissue non-specific alkaline phosphatase fusion protein; Methotrexate; Other: High resolution peripheral quantitative computed tomography (HRpQCT); Other: Microindentation; Retrospective Case Only; Strensiq

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	EUCTR2015-000809-39-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-nonspecific alkaline phosphatase fusion protein) Treatment for Patients with Infantile- or Juvenile-onset Hypophosphatasia (HPP)	Hypophosphatasia MedDRA version: 18.0;Level: PT;Classification code 10049933;Term: Hypophosphatasia;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]	Trade Name: Strensiq Product Name: Asfotas Alfa Product Code: ENB-0040 INN or Proposed INN: ASFOTASE ALFA Other descriptive name: Human Recombinant Tissue Non-Specific Alkaline Phosphatase Fusion Protein	Alexion Pharma International Sàrl	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 4	France;Belgium;Spain;Russian Federation;Netherlands

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agemin

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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-nonspecific alkaline phosphatase fusion protein) Treatment for Patients with Infantile- or Juvenile-onset Hypophosphatasia (HPP)

Hypophosphatasia
MedDRA version: 18.0;Level: PT;Classification code 10049933;Term: Hypophosphatasia;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]

Trade Name: Strensiq
Product Name: Asfotas Alfa
Product Code: ENB-0040
INN or Proposed INN: ASFOTASE ALFA
Other descriptive name: Human Recombinant Tissue Non-Specific Alkaline Phosphatase Fusion Protein

Alexion Pharma International Sàrl

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 4

France;Belgium;Spain;Russian Federation;Netherlands