AstraZeneca: Hypophosphatasia trials

The registry lists 25 Hypophosphatasia studies with AstraZeneca as lead sponsor. 4 are open to participants now and 12 have results posted.

Phase 1 3Phase 2 8Phase 3 4Phase 4 3No phase 9(a study in two phases counts in both)

Studies

Open to participants first, then studies with results posted, then the rest; newest registration first within each.

• Clarify HPP: Disease Burden of HPP Patients in ChinaRecruitingNCT07905287
• The Effect of Monoallelic Variants in the ALPL Gene on the Natural Course of Hypophosphatasia in RussiaRecruitingNCT07390240
• A Prospective Sub-Study of the Global Hypophosphatasia RegistryRecruitingNCT05234567
• Registry of Patients With HypophosphatasiaEnrolling by invitationNCT02306720
• Study of ALXN1850 in Participants With Hypophosphatasia (HPP)CompletedNCT04980248Phase 1Results posted
• Pharmacokinetic and Dose Response Study of Asfotase Alfa in Adult Patients With Pediatric-Onset Hypophosphatasia (HPP)CompletedNCT02797821Phase 2Results posted
• Post-approval Clinical Study of Asfotase Alfa Treatment for Patients With Hypophosphatasia (HPP) in JapanCompletedNCT02531867Phase 4Results posted
• Non-interventional Substudy of ALX-HPP-502 to Assess Natural History of Patients With Juvenile-onset HPP Who Served as Historical Controls in ENB-006-09CompletedNCT02235493Results posted
• Retrospective, Non-interventional Natural History of Patients With Juvenile-onset Hypophosphatasia (HPP)CompletedNCT02104219Results posted
• A Retrospective Study of the Natural History of Patients With Severe Perinatal and Infantile Hypophosphatasia (HPP)CompletedNCT01419028Results posted
• Extension Study of Protocol ENB-002-08 - Study of Asfotase Alfa in Infants and Young Children With Hypophosphatasia (HPP)CompletedNCT01205152Phase 2Results posted
• Extension Study of Protocol ENB-006-09 - Study of Asfotase Alfa in Children With Hypophosphatasia (HPP)CompletedNCT01203826Phase 2Results posted
• Open-Label Study of Asfotase Alfa in Infants and Children ≤ 5 Years of Age With Hypophosphatasia (HPP)CompletedNCT01176266Phase 2/3Results posted
• Safety and Efficacy Study of Asfotase Alfa in Adolescents and Adults With Hypophosphatasia (HPP)CompletedNCT01163149Phase 2Results posted
• Safety and Efficacy of Asfotase Alfa in Juvenile Patients With Hypophosphatasia (HPP)CompletedNCT00952484Phase 2Results posted
• Safety and Efficacy Study of Asfotase Alfa in Severely Affected Infants With Hypophosphatasia (HPP)CompletedNCT00744042Phase 1/2Results posted
• Phase 3 Study of ALXN1850 in Pediatric Participants With HPP Previously Treated With Asfotase AlfaActive, not recruitingNCT06079372Phase 3
• Phase 3 Study of ALXN1850 in Treatment-Naïve Pediatric Participants With HPPActive, not recruitingNCT06079359Phase 3
• Phase 3 Study of ALXN1850 Versus Placebo in Adolescent and Adult Participants With HPP Who Have Not Previously Been Treated With Asfotase AlfaActive, not recruitingNCT06079281Phase 3
• Mitigate Immune-Mediated Loss of Therapeutic Response to Asfotase Alfa (STRENSIQ®) for HypophosphatasiaWithdrawnNCT06015750Phase 4
• Patient Reported Outcomes in Adults With Pediatric-onset Hypophosphatasia Treated With Strensiq® (Asfotase Alfa)CompletedNCT04195763
• Relieving Burden of Hypophosphatasia in Adults With Functional Impairment Due to Chronic DiseaseWithdrawnNCT04189315Phase 4
• Expanded Access Program for Asfotase Alfa Treatment for Patients With Infantile- or Juvenile-onset Hypophosphatasia (HPP)Approved for marketingNCT02496689
• Safety and Efficacy Study of ENB-0040 in Juvenile Patients With Hypophosphatasia (HPP)WithdrawnNCT00894075Phase 2
• Safety Study of Human Recombinant Tissue Non-Specific Alkaline Phosphatase Fusion Protein Asfotase Alfa in Adults With Hypophosphatasia (HPP)CompletedNCT00739505Phase 1