Retrospective, Non-interventional Natural History of Patients With Juvenile-onset Hypophosphatasia (HPP)

Study Identifier:
ALX-HPP-502
ClinicalTrials.gov Identifier:
NCT02104219
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
    Date
    Mar 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 unless patient is deceased
    • Patients with Juvenile-onset HPP, defined as documented onset of first signs/symptoms at ≥ 6 months to ˂18 years
    • Documented diagnosis of HPP as indicated by skeletal manifestations and low alkaline phosphatase or genotyping
    Exclusion Criteria
    • Received treatment with asfotase alfa in the ENB-006-09 study and/or currently enrolled in the ENB-008-10 study
    • Received other treatment and/or intervention to treat HPP up to 15 years old
    • Other clinically significant disease
    Sex
    Female & Male
    Age
    5+ years

    Study Details

    Medical Condition
    • Unmapped
    Study Drug
      Date
      Mar 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 unless patient is deceased
      • Patients with Juvenile-onset HPP, defined as documented onset of first signs/symptoms at ≥ 6 months to ˂18 years
      • Documented diagnosis of HPP as indicated by skeletal manifestations and low alkaline phosphatase or genotyping
      Exclusion Criteria
      • Received treatment with asfotase alfa in the ENB-006-09 study and/or currently enrolled in the ENB-008-10 study
      • Received other treatment and/or intervention to treat HPP up to 15 years old
      • Other clinically significant disease

      Protocol Summary

      The purpose of this study is to characterize the natural history of HPP in patients with Juvenile-onset HPP.

      Trial Locations

      Location
      Status
      Location
      Atlanta, Georgia, United States
      Status
      N/A
      Location
      Indianapolis, Indiana, United States
      Status
      N/A
      Location
      Boston, Massachusetts, United States
      Status
      N/A
      Location
      Springfield, Missouri, United States
      Status
      N/A
      Location
      St Louis, Missouri, United States
      Status
      N/A
      Location
      Durham, North Carolina, United States
      Status
      N/A
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