drugset / Trial / NCT00739505
Safety Study of Human Recombinant Tissue Non-Specific Alkaline Phosphatase Fusion Protein Asfotase Alfa in Adults With Hypophosphatasia (HPP)
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This clinical trial studies the safety, tolerability, and pharmacology of asfotase alfa when given to adults with HPP.
Timeline
- Start
- 2008-08
- Primary completion
- 2009-01
- Completion
- 2009-02
Publications
- Background Millan JL, Narisawa S, Lemire I, Loisel TP, Boileau G, Leonard P, Gramatikova S, Terkeltaub R, Camacho NP, McKee MD, Crine P, Whyte MP. Enzyme replacement therapy for murine hypophosphatasia. J Bone Miner Res. 2008 Jun;23(6):777-87. doi: 10.1359/jbmr.071213.
- Background Drake MT, Khosla S. Bone-targeted replacement therapy for hypophosphatasia. J Bone Miner Res. 2008 Jun;23(6):775-6. doi: 10.1359/jbmr.080305. No abstract available.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | asfotase alfa | Protein / enzyme biologic | 1 mg/kg | Intravenous |
| Subject | asfotase alfa | Protein / enzyme biologic | 1.5 mg/kg | Intravenous |