Safety and Efficacy Study of Asfotase Alfa in Adolescents and Adults With Hypophosphatasia (HPP)
Study Identifier:
ENB-009-10
ClinicalTrials.gov Identifier:
EudraCT Identifier:
N/A
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
N/A
Study Complete
Study Details
Medical Condition
- Unmapped
Study Drug
- Drug: asfotase alfa
Date
Jun 2010 - Jun 2016
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 13 - 65 Years
Requirements Information
Sex
Female & Male
Age
13 - 65 Years
Study Details
Medical Condition
- Unmapped
Study Drug
- Drug: asfotase alfa
Date
Jun 2010 - Jun 2016
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 13 - 65 Years years
Requirements Information
Protocol Summary
This clinical trial was conducted to study hypophosphatasia (HPP), a bone disorder caused by gene mutations or changes. These gene mutations cause low levels of an enzyme needed to harden bone. The purpose of this study was to test the safety and efficacy of two doses of the study drug called asfotase alfa as compared to a control group to see effects on adolescents and adults with HPP.
Trial Locations
Location
Status
Location
Shriner's Hospital for Children
Saint Louis, Missouri, United States, 63131
Status
N/A
Location
Duke University Medical Center
Durham, North Carolina, United States, 27710
Status
N/A
Location
Health Sciences Centre Winnipeg, University of Manitoba
Winnipeg, Manitoba, Canada, R3A 1S1
Status
N/A