Status:
COMPLETED
Extension Study of Protocol ENB-006-09 - Study of Asfotase Alfa in Children With Hypophosphatasia (HPP)
Lead Sponsor:
Alexion Pharmaceuticals, Inc.
Conditions:
Hypophosphatasia (HPP)
Eligibility:
All Genders
5-12 years
Phase:
PHASE2
Brief Summary
This clinical trial studies the long term safety and efficacy of asfotase alfa in children with HPP who completed Study ENB-006-09 (NCT00952484).
Detailed Description
Asfotase alfa was formerly referred to as ENB-0040 Hypophosphatasia (HPP) is a life-threatening, genetic, and ultra-rare metabolic disease characterized by defective bone mineralization and impaired ...
Eligibility Criteria
Inclusion
- Compliant and satisfactory completion of Enobia-sponsored clinical trial ENB-006-09
- Written informed consent by parent or other legal guardian prior to any study procedures being performed
- Parent or other legal guardian willing to comply with study requirements
Exclusion
- Clinically significant disease that precludes study participation, in the Investigator's opinion
- Treatment with an investigational drug other than asfotase alfa
- Enrollment in any study (other than ENB-006-09) involving an investigational drug, device, or treatment for HPP
- Prior treatment with bisphosphonates
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01203826
Start Date
April 1 2010
End Date
June 1 2016
Last Update
March 13 2019
Active Locations (2)
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1
Shriners Hospital for Children
St Louis, Missouri, United States, 63110
2
Children's Hospital Health Sciences Centre
Winnipeg, Manitoba, Canada, R3A 1S1