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
    Jan 2015 - 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
    • 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
      Jan 2015 - 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
      • 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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