A Study of Lanadelumab in Persons With Hereditary Angioedema (HAE) Type I or II in North America (EMPOWER)

Shire

Status: Completed

Conditions: Hereditary Angioedema (HAE)

Study type: Observational

Funder types: Industry

Identifiers

NCT03845400

SHP643-403

TAK-743-403 (Other Identifier)

Details and patient eligibility

About

The main aim of this study is to compare the HAE attack rate before and after lanadelumab treatment was started in persons with Hereditary Angioedeme Type I or II.

Data from participants will be collected for at least 24 months. Participants will report information in a smartphone application at study start and then every 3 months until the study ends; data will also be collected by the study doctor during routine clinic visits.

Enrollment: 168 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

168 participants in 1 patient group

Type I or Type II HAE Participants

Description:

Participants with Type I or Type II HAE will be followed for 24 or 36 months depending upon enrollment date. Data collection will cease at the end of follow-up period, at the time of withdrawal, lost to follow-up, or death whichever comes first.