Extension Study of Protocol ENB-002-08 - Study of Asfotase Alfa in Infants and Young Children With Hypophosphatasia (HPP)

Study Identifier:
ENB-003-08
ClinicalTrials.gov Identifier:
NCT01205152
EudraCT Identifier:
N/A
EU CT ID:
N/A
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
N/A
Study Complete

Study Details

Medical Condition
  • Unmapped
Study Drug
  • Biological: asfotase alfa
Date
Apr 2009 - Aug 2016
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 24 Weeks - 42 Months
Requirements Information
Inclusion and Exclusion Criteria
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)
Sex
Female & Male
Age
24 Weeks - 42 Months

Study Details

Medical Condition
  • Unmapped
Study Drug
  • Biological: asfotase alfa
Date
Apr 2009 - Aug 2016
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 24 Weeks - 42 Months years
Requirements Information
Inclusion and Exclusion Criteria
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)

Protocol 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 this study was provided by the Office of Orphan Product Development (OOPD).

Trial Locations

Location
Status
Location
Alfred I. DuPont Hospital for Children
Wilmington, Delaware, United States, 19803
Status
N/A
Location
St. John's Medical Research Institute
Springfield, Missouri, United States, 65807
Status
N/A
Location
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Status
N/A
Location
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Status
N/A
Location
St. Vincent Hospital
Green Bay, Wisconsin, United States, 54301
Status
N/A
Location
Tawam Hospital
Al Ain City, Abu Dhabi Emirate, United Arab Emirates
Status
N/A
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