Status:
COMPLETED
Extension Study of Protocol ENB-002-08 - Study of Asfotase Alfa in Infants and Young Children With Hypophosphatasia (HPP)
Lead Sponsor:
Alexion Pharmaceuticals, Inc.
Conditions:
Hypophosphatasia
Eligibility:
All Genders
24-42 years
Phase:
PHASE2
Brief Summary
This clinical trial studied the long term safety and efficacy of asfotase alfa in infants and young children with infantile onset HPP who completed study ENB-002-08 (NCT00744042). Partial funding for...
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
- Inclusion Criteria
- Patient completed participation in ENB-002-08 (NCT00744042)
- 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 Criteria
- History of sensitivity to any of the constituents of the study drug
- Clinically significant disease that precludes study participation
- Enrollment in any study (other than ENB-002-08) involving an investigational drug, device, or treatment for HPP (e.g., bone marrow transplantation)
Exclusion
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2016
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01205152
Start Date
April 1 2009
End Date
August 1 2016
Last Update
March 13 2019
Active Locations (8)
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1
Alfred I. DuPont Hospital for Children
Wilmington, Delaware, United States, 19803
2
St. John's Medical Research Institute
Springfield, Missouri, United States, 65807
3
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
4
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232