asfotase alfa
Sponsors
Alexion Pharmaceuticals Inc., Alexion Pharmaceuticals, Inc.
Conditions
HYPOPHOSPHATASIAHypophosphatasiaHypophosphatasia (HPP)
Phase 1
Safety Study of Human Recombinant Tissue Non-Specific Alkaline Phosphatase Fusion Protein Asfotase Alfa in Adults With Hypophosphatasia (HPP)
CompletedNCT00739505
Start: 2008-08-31End: 2009-02-28Updated: 2019-03-29
Safety and Efficacy Study of Asfotase Alfa in Severely Affected Infants With Hypophosphatasia (HPP)
CompletedNCT00744042
Start: 2008-09-30End: 2010-05-31Updated: 2019-04-01
Phase 2
Safety and Efficacy of Asfotase Alfa in Juvenile Patients With Hypophosphatasia (HPP)
CompletedNCT00952484
Start: 2009-09-30End: 2010-07-31Updated: 2019-04-01
Safety and Efficacy Study of Asfotase Alfa in Adolescents and Adults With Hypophosphatasia (HPP)
CompletedNCT01163149
Start: 2010-06-30End: 2016-06-30Updated: 2019-03-13
Open-Label Study of Asfotase Alfa in Infants and Children ≤ 5 Years of Age With Hypophosphatasia (HPP)
CompletedNCT01176266
Start: 2010-07-31End: 2016-09-30Updated: 2019-03-13
Extension Study of Protocol ENB-006-09 - Study of Asfotase Alfa in Children With Hypophosphatasia (HPP)
CompletedNCT01203826
Start: 2010-04-30End: 2016-06-30Updated: 2019-03-13
Extension Study of Protocol ENB-002-08 - Study of Asfotase Alfa in Infants and Young Children With Hypophosphatasia (HPP)
CompletedNCT01205152
Start: 2009-04-30End: 2016-08-31Updated: 2019-03-13
Pharmacokinetic and Dose Response Study of Asfotase Alfa in Adult Patients With Pediatric-Onset Hypophosphatasia (HPP)
CompletedNCT02797821
Start: 2016-06-06End: 2017-06-21Updated: 2019-09-17
Phase 3
Phase 4
Post-approval Clinical Study of Asfotase Alfa Treatment for Patients With Hypophosphatasia (HPP) in Japan
CompletedNCT02531867
Start: 2015-06-30End: 2015-11-30Updated: 2017-05-08
Relieving Burden of Hypophosphatasia in Adults With Functional Impairment Due to Chronic Disease
WithdrawnNCT04189315
Start: 2020-04-30End: 2022-08-31Updated: 2020-06-04
An Interventional, Prospective Open-Label Study of Immunosuppressive Therapies to Mitigate Immune-Mediated Loss of Therapeutic Response to Asfotase Alfa (STRENSIQ®) for Hypophosphatasia (RESTORE)
CompletedCTIS2022-502793-17-00
End: 2025-08-08Target: 1Updated: 2024-09-19
Unknown Phase
Expanded Access Program for Asfotase Alfa Treatment for Patients With Infantile- or Juvenile-onset Hypophosphatasia (HPP)
NCT02496689
Updated: 2019-03-29
Patient Reported Outcomes in Adults With Pediatric-onset Hypophosphatasia Treated With Strensiq® (Asfotase Alfa)
CompletedNCT04195763
Start: 2019-11-06End: 2024-04-12Updated: 2024-07-10
A Prospective Sub-Study of the Global Hypophosphatasia Registry
RecruitingNCT05234567
Start: 2022-08-25End: 2028-07-18Target: 30Updated: 2026-02-09