A Multicenter study of the safety and efficacy of Asfotase Alfa (ALXN1215) (Human Recombinant Tissue Nonspecific Alkaline Phosphatase Fusion Protein) in patients with hypophosphatasia (HPP)
- Conditions
- hypophosphatasia
- Registration Number
- JPRN-UMIN000014816
- Lead Sponsor
- HPP study group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 20
Not provided
Patients will be excluded from enrollment in this study if they meet any of the following exclusion criteria: 1. Current evidence of treatable form of rickets 2. Serum calcium or phosphate levels below the normal range 3. Pregnant women and nursing mothers 4. Patient who cannot enforce suitable contraceptive measures during the clinical trial 5. Prior treatment with bisphosphonates Treatment with an investigational drug within 1 month prior to the start of asfotase alfa treatment 7. Current enrollment in any other study involving an investigational new drug, device or treatment for HPP (e.g., bone marrow transplantation) 8. Clinically significant disease that precludes study participation, in the opinion of the Investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method