Open-Label Study of Asfotase Alfa in Infants and Children ≤ 5 Years of Age With Hypophosphatasia (HPP)
Study Identifier:
ENB-010-10
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
Jul 2010 - Sep 2016
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 1 Minute - 5 Years
Requirements Information
Sex
Female & Male
Age
1 Minute - 5 Years
Study Details
Medical Condition
- Unmapped
Study Drug
- Drug: asfotase alfa
Date
Jul 2010 - Sep 2016
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 1 Minute - 5 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 a study drug called asfotase alfa (human recombinant tissue non-specific alkaline phosphate fusion protein) to see what effects it has on patients 5 years of age or less with HPP.
Trial Locations
Location
Status
Location
Children's Hospital & Research Center Oakland
Oakland, California, United States, 94609
Status
N/A
Location
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Status
N/A
Location
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States, 15224
Status
N/A
Location
Lady Cilento Children's Hospital
South Brisbane, Queensland, Australia, 4101
Status
N/A
Location
Royal Children'S Hospital Melbourne
Parkville, Victoria, Australia, 3052
Status
N/A
Location
Health Sciences Centre Winnipeg, University of Manitoba
Winnipeg, Manitoba, Canada, R3A 1S1
Status
N/A