JPRN-UMIN000014816
Completed
未知
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) - Safety and efficacy of Asfotase Alfa in patients with hypophosphatasia (HPP)
HPP study group0 sites20 target enrollmentAugust 11, 2014
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- HPP study group
- Enrollment
- 20
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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