Trials / Completed
CompletedNCT02531867
Post-approval Clinical Study of Asfotase Alfa Treatment for Patients With Hypophosphatasia (HPP) in Japan
A Multicenter, Post-Approval Clinical Study for Asfotase Alfa (Human Recombinant Tissue-nonspecific Alkaline Phosphatase Fusion Protein) Treatment for Patients With Hypophosphatasia (HPP) in Japan
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 13 (actual)
- Sponsor
- Alexion Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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.
Detailed description
The primary objective of this study was to collect data on the safety of repeated subcutaneous (SC) injections of asfotase alfa. There were no secondary objectives. Exploratory objectives related to the efficacy of asfotase alfa are not being reported.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Asfotase Alfa |
Timeline
- Start date
- 2015-06-01
- Primary completion
- 2015-11-01
- Completion
- 2015-11-01
- First posted
- 2015-08-25
- Last updated
- 2017-05-08
- Results posted
- 2017-05-08
Source: ClinicalTrials.gov record NCT02531867. Inclusion in this directory is not an endorsement.