Paroxysmal Nocturnal Hemoglobinuria (PNH) Registry

Study Identifier:
M07-001
ClinicalTrials.gov Identifier:
NCT01374360
EudraCT Identifier:
N/A
EU CT ID:
N/A
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
N/A
Study Complete

Study Details

Medical Condition
  • Paroxysmal Nocturnal Hemoglobinuria
Study Drug
    Date
    Oct 2004 - Aug 2024
    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
    • Patients of any age, including minors, with a diagnosis of PNH or a detected PNH clone, including patients previously treated with Soliris or Ultomiris and withdrawn from treatment. Patients who are minors must have parent/legal guardian consent and must be willing and able to give assent, if applicable as determined by the Ethics Committees/Institutional Review Boards. Upon attaining adulthood, these patients must be re-consented.
    • Ability to comprehend and sign consent to have data entered in the PNH Registry.
    Exclusion Criteria
    • Inability or unwillingness to sign informed consent.
    • Patients currently enrolled in an interventional clinical trial for treatment of PNH cannot be enrolled in the Registry at the same time.
    Sex
    Female & Male
    Age
    N/A

    Study Details

    Medical Condition
    • Paroxysmal Nocturnal Hemoglobinuria
    Study Drug
      Date
      Oct 2004 - Aug 2024
      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
      • Patients of any age, including minors, with a diagnosis of PNH or a detected PNH clone, including patients previously treated with Soliris or Ultomiris and withdrawn from treatment. Patients who are minors must have parent/legal guardian consent and must be willing and able to give assent, if applicable as determined by the Ethics Committees/Institutional Review Boards. Upon attaining adulthood, these patients must be re-consented.
      • Ability to comprehend and sign consent to have data entered in the PNH Registry.
      Exclusion Criteria
      • Inability or unwillingness to sign informed consent.
      • Patients currently enrolled in an interventional clinical trial for treatment of PNH cannot be enrolled in the Registry at the same time.

      Protocol Summary

      This study is a collection of data to evaluate safety and characterize progression of Paroxysmal Nocturnal Hemoglobinuria (PNH).

      Trial Locations

      Location
      Status
      Location
      Contact the PNH Registry at Alexion Pharmaceuticals, Inc. for worldwide locations.
      Boston, Massachusetts, United States, 02210
      Status
      N/A