Registry of Patients With Hypophosphatasia

Study Identifier:
ALX-HPP-501
ClinicalTrials.gov Identifier:
NCT02306720
EudraCT Identifier:
N/A
EU CT ID:
N/A
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
N/A
Recruiting

Study Details

Medical Condition
  • Unmapped
Study Drug
    Date
    Apr 2017 - Dec 2031
    Phase 1
    Phase 2
    Phase 3
    Phase 4
    N/A
    Patient Requirements
    Sex: Female & Male
    Age: N/A
    Requirements Information
    Inclusion and Exclusion Criteria
    Inclusion Criteria
    • Male and female participants, of any age, with a confirmed diagnosis of HPP.
    • Participant must have documented alkaline phosphatase (ALP) activity below the lower limit of normal for age and sex, or a documented ALPL gene mutation.
    • Participant or legal representative is able to read and/or understand the informed consent and study questionnaires in the local language.
    • Signed informed consent and medical records release by the patient or legal representative. Patient or patient's parent/legal representative must be willing and able to give written informed consent, and the patient must be willing to give written informed assent, if appropriate and required by local regulations.
    Exclusion Criteria
    • Currently participating in an Alexion-sponsored clinical trial. Enrollment in the Registry will not exclude a patient from enrolling in a future clinical trial.
    Sex
    Female & Male
    Age
    N/A

    Study Details

    Medical Condition
    • Unmapped
    Study Drug
      Date
      Apr 2017 - Dec 2031
      Phase 1
      Phase 2
      Phase 3
      Phase 4
      N/A
      Patient Requirements
      Sex: Female & Male
      Age: N/A years
      Requirements Information
      Inclusion and Exclusion Criteria
      Inclusion Criteria
      • Male and female participants, of any age, with a confirmed diagnosis of HPP.
      • Participant must have documented alkaline phosphatase (ALP) activity below the lower limit of normal for age and sex, or a documented ALPL gene mutation.
      • Participant or legal representative is able to read and/or understand the informed consent and study questionnaires in the local language.
      • Signed informed consent and medical records release by the patient or legal representative. Patient or patient's parent/legal representative must be willing and able to give written informed consent, and the patient must be willing to give written informed assent, if appropriate and required by local regulations.
      Exclusion Criteria
      • Currently participating in an Alexion-sponsored clinical trial. Enrollment in the Registry will not exclude a patient from enrolling in a future clinical trial.

      Protocol Summary

      In this prospective, observational, long term registry patients of all ages with a diagnosis of hypophosphatasia (HPP) are followed at participating sites in multiple countries.

      Trial Locations

      Location
      Status
      Location
      Research Site
      Centennial, Colorado, United States, 80112
      Status
      N/A
      Location
      Research Site
      Hartford, Connecticut, United States, 06106
      Status
      N/A
      Location
      Research Site
      Tampa, Florida, United States, 33606
      Status
      N/A
      Location
      Research Site
      Decatur, Georgia, United States, 30033
      Status
      N/A
      Location
      Research Site
      Baltimore, Maryland, United States, 21287
      Status
      N/A
      Location
      Research Site
      Boston, Massachusetts, United States, 02111
      Status
      N/A
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