Extension Study of Protocol ENB-006-09 - Study of Asfotase Alfa in Children With Hypophosphatasia (HPP)

Study Identifier:
ENB-008-10
ClinicalTrials.gov Identifier:
NCT01203826
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 2010 - Jun 2016
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 5 - 12 Years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • 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 Criteria
  • 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
Sex
Female & Male
Age
5 - 12 Years

Study Details

Medical Condition
  • Unmapped
Study Drug
  • Biological: Asfotase Alfa
Date
Apr 2010 - Jun 2016
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 5 - 12 Years years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • 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 Criteria
  • 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

Protocol 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).

Trial Locations

Location
Status
Location
Shriners Hospital for Children
St Louis, Missouri, United States, 63110
Status
N/A
Location
Children's Hospital Health Sciences Centre
Winnipeg, Manitoba, Canada, R3A 1S1
Status
N/A