Hypophosphatasia
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CLINICAL_TRIALS trial_result · 2017-11-17Clinical Trial Update: Extension Study of Protocol ENB-002-08 - Study of Asfotase Alfa in Infants and Young Children With Hypophosphatasia (HPP) [Phase 2]
Extension study update for asfotase alfa in infants and young children with hypophosphatasia (Phase 2) completed; results posted in 2017.
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CLINICAL_TRIALS trial_result · 2017-09-18Clinical Trial Update: Safety and Efficacy Study of Asfotase Alfa in Adolescents and Adults With Hypophosphatasia (HPP) [Phase 2]
A Phase 2 trial evaluating safety and efficacy of asfotase alfa in adolescents and adults with hypophosphatasia has completed with results p…
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CLINICAL_TRIALS trial_result · 2017-07-26Clinical Trial Update: Extension Study of Protocol ENB-006-09 - Study of Asfotase Alfa in Children With Hypophosphatasia (HPP) [Phase 2]
Extension study update for asfotase alfa in children with hypophosphatasia (Phase 2) completed with results posted in 2017.
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CLINICAL_TRIALS trial_result · 2017-05-08Clinical Trial Update: Post-approval Clinical Study of Asfotase Alfa Treatment for Patients With Hypophosphatasia (HPP) in Japan [Phase 4]
This document reports results from a Phase 4 post-approval clinical study of asfotase alfa in Japanese patients with hypophosphatasia.
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CLINICAL_TRIALS trial_result · 2016-11-08Clinical Trial Update: Burden of Disease in Hypophosphatasia (HPP)
An update on the completed clinical trial NCT02291497 evaluating the burden of disease in hypophosphatasia, sponsored by Würzburg University…
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FDA approval · 2016-10-18FDA Approved: STRENSIQ — Supplemental Application (Alexion Pharmaceuticals, Inc.)
The FDA approves a supplemental application for STRENSIQ (asfotase alfa) from Alexion Pharmaceuticals. This action updates the approved labe…
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CLINICAL_TRIALS trial_result · 2016-03-31Clinical Trial Update: Safety and Efficacy of Asfotase Alfa in Patients With Hypophosphatasia (HPP) [Phase 2]
A Phase 2 clinical trial evaluating the safety and efficacy of asfotase alfa in patients with hypophosphatasia has completed.
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CLINICAL_TRIALS trial_result · 2015-12-18Clinical Trial Update: Retrospective, Non-interventional Natural History of Patients With Juvenile-onset Hypophosphatasia (HPP)
Retrospective, non-interventional natural history study of juvenile-onset hypophosphatasia completed with results posted in 2015.
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FDA approval · 2015-10-23FDA Approved: STRENSIQ — Original Application (Alexion Pharmaceuticals, Inc.)
The FDA approved STRENSIQ (asfotase alfa) from Alexion Pharmaceuticals in its original Biologics License Application, establishing enzyme re…
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CLINICAL_TRIALS research · 2015-09-28Clinical Trial Update: Non-interventional Substudy of ALX-HPP-502 to Assess Natural History of Patients With Juvenile-onset HPP Who Served as Historical Controls in ENB-006-09
Non-interventional substudy to assess natural history of juvenile-onset hypophosphatasia using historical controls from ENB-006-09; complete…
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CLINICAL_TRIALS research · 2014-07-21Clinical Trial Update: A Retrospective Study of the Natural History of Patients With Severe Perinatal and Infantile Hypophosphatasia (HPP)
A retrospective study analyzing the natural history of severe perinatal and infantile hypophosphatasia (HPP).
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CLINICAL_TRIALS trial_result · 2011-09-30Clinical Trial Update: Safety and Efficacy Study of Asfotase Alfa in Severely Affected Infants With Hypophosphatasia (HPP) [Phase 1, Phase 2]
A Phase 1/2 safety and efficacy study of asfotase alfa in severely affected infants with hypophosphatasia has completed, with results posted…
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CLINICAL_TRIALS trial_result · 2011-07-26Clinical Trial Update: Safety and Efficacy of Asfotase Alfa in Juvenile Patients With Hypophosphatasia (HPP) [Phase 2]
Phase 2 trial evaluating safety and efficacy of asfotase alfa in juvenile patients with hypophosphatasia has completed with results posted.