11 completed, 2 withdrawn, 1 active not recruiting, 1 approved for marketing. 9 Phase 2, 2 Phase 1, 2 Phase 3, 2 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 9 | Completed 8, Withdrawn 1 |
| Phase 1 | 2 | Completed 2 |
| Phase 3 | 2 | Active not recruiting 1, Completed 1 |
| Phase 4 | 2 | Completed 1, Withdrawn 1 |
Follow asfotase alfa: new trials by email Literature Review of asfotase alfa trials Research Report on asfotase alfa
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Phase 3 Study of ALXN1850 in Pediatric Participants With HPP Previously Treated With Asfotase Alfa ALXN1850, asfotase alfa - Hypophosphatasia | Phase 3 | Active not recruiting | Alexion Pharmaceuticals, Inc. | 43 | 2024-04-02 | 2026-05-05 |
| A Prospective Sub-Study of the Global Hypophosphatasia Registry Asfotase Alfa - Hypophosphatasia | Recruiting | Alexion Pharmaceuticals, Inc. | 30 | 2022-08-25 | 2026-02-09 | |
| Relieving Burden of Hypophosphatasia in Adults With Functional Impairment Due to Chronic Disease asfotase alfa - Hypophosphatasia | Phase 4 | Withdrawn | Alexion Pharmaceuticals, Inc. | 2020-04-01 | 2020-06-04 | |
| Patient Reported Outcomes in Adults With Pediatric-onset Hypophosphatasia Treated With Strensiq® (Asfotase Alfa) asfotase alfa - Hypophosphatasia | Completed | Alexion Pharmaceuticals, Inc. | 50 | 2019-11-06 | 2024-07-10 | |
| Pharmacokinetic and Dose Response Study of Asfotase Alfa in Adult Patients With Pediatric-Onset Hypophosphatasia (HPP) Asfotase alfa - Hypophosphatasia | Phase 2 | Completed | Alexion Pharmaceuticals, Inc. | 27 | 2016-06-06 | 2019-09-17 |
| Post-approval Clinical Study of Asfotase Alfa Treatment for Patients With Hypophosphatasia (HPP) in Japan Asfotase Alfa - Hypophosphatasia | Phase 4 | Completed | Alexion Pharmaceuticals, Inc. | 13 | 2015-06-01 | 2017-05-08 |
| Safety and Efficacy of Asfotase Alfa in Patients With Hypophosphatasia (HPP) Asfotase Alfa (ALXN1215) - Hypophosphatasia | Phase 2 | Completed | Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan | 13 | 2014-08-01 | 2016-03-31 |
| Open-Label Study of Asfotase Alfa in Infants and Children ≤ 5 Years of Age With Hypophosphatasia (HPP) asfotase alfa - Hypophosphatasia | Phase 2 / Phase 3 | Completed | Alexion Pharmaceuticals, Inc. | 69 | 2010-07-01 | 2019-03-13 |
| Safety and Efficacy Study of Asfotase Alfa in Adolescents and Adults With Hypophosphatasia (HPP) asfotase alfa - Hypophosphatasia | Phase 2 | Completed | Alexion Pharmaceuticals, Inc. | 19 | 2010-06-01 | 2019-03-13 |
| Extension Study of Protocol ENB-006-09 - Study of Asfotase Alfa in Children With Hypophosphatasia (HPP) Asfotase Alfa - Hypophosphatasia (HPP) | Phase 2 | Completed | Alexion Pharmaceuticals, Inc. | 12 | 2010-04-01 | 2019-03-13 |
| Safety and Efficacy of Asfotase Alfa in Juvenile Patients With Hypophosphatasia (HPP) asfotase alfa - Hypophosphatasia (HPP) | Phase 2 | Completed | Alexion Pharmaceuticals, Inc. | 13 | 2009-09-01 | 2019-04-01 |
| Safety and Efficacy Study of ENB-0040 in Juvenile Patients With Hypophosphatasia (HPP) ENB-0040 - Hypophosphatasia | Phase 2 | Withdrawn | Alexion Pharmaceuticals, Inc. | 2009-07-01 | 2023-08-04 | |
| Extension Study of Protocol ENB-002-08 - Study of Asfotase Alfa in Infants and Young Children With Hypophosphatasia (HPP) asfotase alfa - Hypophosphatasia | Phase 2 | Completed | Alexion Pharmaceuticals, Inc. | 10 | 2009-04-01 | 2019-03-13 |
| Safety and Efficacy Study of Asfotase Alfa in Severely Affected Infants With Hypophosphatasia (HPP) asfotase alfa - Hypophosphatasia (HPP) | Phase 1 / Phase 2 | Completed | Alexion Pharmaceuticals, Inc. | 11 | 2008-09-01 | 2019-04-01 |
| Safety Study of Human Recombinant Tissue Non-Specific Alkaline Phosphatase Fusion Protein Asfotase Alfa in Adults With Hypophosphatasia (HPP) Asfotase Alfa - Hypophosphatasia (HPP) | Phase 1 | Completed | Alexion Pharmaceuticals, Inc. | 6 | 2008-08-01 | 2019-03-29 |
| Expanded Access Program for Asfotase Alfa Treatment for Patients With Infantile- or Juvenile-onset Hypophosphatasia (HPP) asfotase alfa - Hypophosphatasia | Approved for marketing | Alexion Pharmaceuticals, Inc. | 2019-03-29 |
Hypophosphatasia (16) · Osteomalacia (10) · Rickets (10) · Bone Diseases (9)
Alexion Pharmaceuticals, Inc. (15) · Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan (1)
United States (12) · Canada (7) · United Kingdom (4) · Japan (3) · Australia (2) · France (2) · Germany (2) · Turkey (Türkiye) (2) · United Arab Emirates (2) · Argentina (1) · Italy (1) · Russia (1) · Saudi Arabia (1) · Spain (1)
Andrew Denker, MD, PhD (1) · Keiichi Ozono (1) · Kenji Fujita, MD (1) · Michael P. Whyte, MD (1)
PMID 26529632, PMID 32417537, PMID 32762706, PMID 27699270, PMID 22397652, PMID 30558909, PMID 30811537, PMID 30969260, PMID 32987199, PMID 33822385