Summary

Location
at San Diego, California and other locations
Dates
study started
estimated completion

Description

Summary

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.

Official Title

An Observational, Non-interventional, Study of Patients With Hereditary Angioedema in the United States and Canada (EMPOWER Study)

Keywords

Hereditary Angioedema (HAE) Angioedema Angioedemas, Hereditary

Eligibility

You can join if…

  • 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.

You CAN'T join if...

  • 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.

Locations

  • University of California San Diego in progress, not accepting new patients
    San Diego California 92122 United States
  • AIRE Medical of Los Angeles accepting new patients
    Santa Monica California 90404 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Shire
ID
NCT03845400
Study Type
Observational
Last Updated