Status:
COMPLETED
A Study of Lanadelumab in Persons With Hereditary Angioedema (HAE) Type I or II in North America
Lead Sponsor:
Shire
Collaborating Sponsors:
Takeda Development Center Americas, Inc.
Conditions:
Hereditary Angioedema (HAE)
Eligibility:
All Genders
Brief Summary
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 coll...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 30 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 22 2022
Estimated Enrollment :
168 Patients enrolled
Trial Details
Trial ID
NCT03845400
Start Date
March 30 2019
End Date
October 22 2022
Last Update
March 30 2023
Active Locations (29)
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1
Clinical Research Center of Alabama
Birmingham, Alabama, United States, 35209
2
Medical Research of Arizona
Scottsdale, Arizona, United States, 85248
3
University of California San Diego
San Diego, California, United States, 92122
4
AIRE Medical of Los Angeles
Santa Monica, California, United States, 90404