Status:
COMPLETED
Non-interventional Substudy of ALX-HPP-502 to Assess Natural History of Patients With Juvenile-onset HPP Who Served as Historical Controls in ENB-006-09
Lead Sponsor:
Alexion Pharmaceuticals, Inc.
Conditions:
Hypophosphatasia
Bone Disease
Eligibility:
All Genders
5+ years
Brief Summary
The purpose of this study is to characterize the natural history of HPP in patients with Juvenile-onset HPP who served as historical controls in ENB-006-09.
Detailed Description
Hypophosphatasia (HPP) is a life-threatening, genetic, and ultra-rare metabolic disease characterized by defective bone mineralization and impaired phosphate and calcium regulation that can lead to pr...
Eligibility Criteria
Inclusion
- Documented informed consent/assent prior to video collection and data abstraction.
- Documented informed consent/assent in Study ALX-HPP-502.
- Patients with juvenile-onset HPP and was selected as a historical-control for Study ENB-006-09.
- Patients with at least 2 videos of basic mobility that were recorded at 2 different clinic visits when the patient was ≥5 to ≤15 ye
Exclusion
- There are no exclusion criteria for this study
Key Trial Info
Start Date :
August 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT02235493
Start Date
August 1 2014
End Date
September 1 2014
Last Update
March 13 2019
Active Locations (1)
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1
St Louis, Missouri, United States