Study to Evaluate the Real-world Effectiveness of Lanadelumab in Participants With Hereditary Angioedema (HAE)
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Skin and Soft Tissue Infections |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 2/21/2019 |
| Start Date: | March 31, 2019 |
| End Date: | September 30, 2023 |
| Contact: | Shire Contact |
| Email: | ClinicalTransparency@shire.com |
| Phone: | +1 866 842 5335 |
An Observational, Non-interventional, Study of Patients With Hereditary Angioedema in the United States and Canada (EMPOWER Study)
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.
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.
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.
We found this trial at
1
site
Cincinnati, Ohio 45231
Principal Investigator: Jonathan Bernstein
Phone: 513-354-1746
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