drugset / Trial / NCT02531867
Post-approval Clinical Study of Asfotase Alfa Treatment for Patients With Hypophosphatasia (HPP) in Japan
NaSingle-groupOpen-labelTreatment
Summary
This is a multicenter study in Japan. Eleven sites which have already participated in the investigator-initiated clinical study (Early Access Program) will participate in this study.The objective of this study is to gain further information on the safety and efficacy of treatment with asfotase alfa.
Timeline
- Start
- 2015-06
- Primary completion
- 2015-11
- Completion
- 2015-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | asfotase alfa | Protein / enzyme biologic | 1 mg/kg | Subcutaneous |
| Subject | asfotase alfa | Protein / enzyme biologic | 2 mg/kg | Subcutaneous |