A Study of Lanadelumab in Persons With Hereditary Angioedema (HAE) Type I or II in North America
Purpose
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.
Condition
- Hereditary Angioedema (HAE)
Eligibility
- Eligible Ages
- All ages
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Type I or Type II HAE Participants | 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. |
More Details
- Status
- Completed
- Sponsor
- Shire