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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02531867
Other study ID # AA-HPP-409
Secondary ID
Status Completed
Phase Phase 4
First received August 11, 2015
Last updated August 4, 2016
Start date July 2015
Est. completion date November 2015

Study information

Verified date August 2016
Source Alexion Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority Japan: Pharmaceuticals and Medical Devices Agency
Study type Interventional

Clinical Trial 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.


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Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Biological:
Asfotase Alfa


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Alexion Pharmaceuticals

Outcome

Type Measure Description Time frame Safety issue
Primary The safety of asfotase alfa will be assessed by routine monitoring of patients about Adverse Events (AEs) including Injection Site Reactions (ISRs) and Injection Associated Reactions (IARs) The severity (mild, moderate or severe)of each AE will be assessed by Common Terminology Criteria for Adverse Events (CTCAE) v. 4.03. Up to 3 months No
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