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Study to Evaluate the Real-world Effectiveness of Lanadelumab in Participants With Hereditary Angioedema (HAE) (EMPOWER)

  • Study HIC#:2000026829
  • Last Updated:04/08/2020

This observational, prospective study aims to evaluate the real-world effectiveness of lanadelumab in participants with hereditary angioedema (HAE). Participant-reported attack diaries and patient-reported outcomes (PROs) as well as physician assessments at standard of care (SoC) visits will be used to describe HAE attack rates, treatment patterns, healthcare utilization and participant quality of life.

  • GenderBoth
  • Start Date04/01/2020
  • End Date09/29/2023

Trial Purpose and Description

This observational, prospective study aims to evaluate the real-world effectiveness of lanadelumab in participants with hereditary angioedema (HAE). Participant-reported attack diaries and patient-reported outcomes (PROs) as well as physician assessments at standard of care (SoC) visits will be used to describe HAE attack rates, treatment patterns, healthcare utilization and participant quality of life.

Eligibility Criteria

Inclusion Criteria:

  • Voluntarily provide written, signed, and dated (personally or via a legally-authorized representative) informed consent/and assent as applicable to participate in the study. Expression of understanding and agreement by fully informed parent(s) or legal guardian is required to permit the investigator to enroll a child in this study. The choice of the terms parental consent or parental permission in different regions may reflect local legal/regulatory and ethical considerations.
  • Diagnosis of HAE Type I or Type II.
  • Ability to use a mobile device for data collection in the study.

Exclusion Criteria:

  • Participation in any interventional clinical trial at the time of enrollment.
  • Unable to provide written, signed, and dated informed consent/assent.
  • Investigator believes that the participant is not a suitable candidate for the study.

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