Non-interventional Substudy of ALX-HPP-502 to Assess Natural History of Patients With Juvenile-onset HPP Who Served as Historical Controls in ENB-006-09

Study Identifier:
ALX-HPP-502s
ClinicalTrials.gov Identifier:
NCT02235493
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: Retrospective Case Only
Date
Aug 2014 - Sep 2014
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 5+ years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • Documented informed consent/assent prior to video collection and data abstraction.
  • Documented informed consent/assent in Study ALX-HPP-502.
  • Patients with juvenile-onset HPP and was selected as a historical-control for Study ENB-006-09.
  • Patients with at least 2 videos of basic mobility that were recorded at 2 different clinic visits when the patient was ≥5 to ≤15 ye
Exclusion Criteria
  • There are no exclusion criteria for this study
Sex
Female & Male
Age
5+ years

Study Details

Medical Condition
  • Unmapped
Study Drug
  • Biological: Retrospective Case Only
Date
Aug 2014 - Sep 2014
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 5+ years years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • Documented informed consent/assent prior to video collection and data abstraction.
  • Documented informed consent/assent in Study ALX-HPP-502.
  • Patients with juvenile-onset HPP and was selected as a historical-control for Study ENB-006-09.
  • Patients with at least 2 videos of basic mobility that were recorded at 2 different clinic visits when the patient was ≥5 to ≤15 ye
Exclusion Criteria
  • There are no exclusion criteria for this study

Protocol Summary

The purpose of this study is to characterize the natural history of HPP in patients with Juvenile-onset HPP who served as historical controls in ENB-006-09.

Trial Locations

Location
Status
Location
St Louis, Missouri, United States
Status
N/A