A Study of Lanadelumab in Persons With Hereditary Angioedema (HAE) Type I or II in North America
NCT ID: NCT03845400
Last Updated: 2023-03-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
168 participants
OBSERVATIONAL
2019-03-30
2022-10-22
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of HAE Type I or Type II.
* Ability to use a mobile device for data collection in the study.
Exclusion Criteria
* Unable to provide written, signed, and dated informed consent/assent.
* Investigator believes that the participant is not a suitable candidate for the study.
ALL
No
Sponsors
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Takeda Development Center Americas, Inc.
INDUSTRY
Shire
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Shire
Locations
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Clinical Research Center of Alabama
Birmingham, Alabama, United States
Medical Research of Arizona
Scottsdale, Arizona, United States
University of California San Diego
San Diego, California, United States
AIRE Medical of Los Angeles
Santa Monica, California, United States
Asthma and Allergy Associates, PC
Colorado Springs, Colorado, United States
Yale University School of Medicine
New Haven, Connecticut, United States
University of South Florida Asthma, Allergy & Immunology
Tampa, Florida, United States
University of Kansas Medical Center Research Institute, Inc.
Kansas City, Kansas, United States
Institute for Asthma & Allergy - Chevy Chase
Chevy Chase, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Mid West Immunology Clinic
Plymouth, Minnesota, United States
Washington University
St Louis, Missouri, United States
Riverside Medical Group, Belleville
Belleville, New Jersey, United States
Jay M Kashkin, MD Allergy, Asthma and Immunology
Fair Lawn, New Jersey, United States
Mount Sinai
New York, New York, United States
Clinical Research of Charlotte
Charlotte, North Carolina, United States
Duke Asthma, Allergy & Airway Center
Durham, North Carolina, United States
Bernstein Clinical Research Center, LLC
Cincinnati, Ohio, United States
Portland Clinical Research/AAIM Care
Happy Valley, Oregon, United States
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States
AARA Research Center
Dallas, Texas, United States
Seattle Allergy & Asthma Research Institute
Seattle, Washington, United States
University of Calgary - Heritage Medical Research Clinic
Calgary, Alberta, Canada
McMaster University Health Sciences Center
Hamilton, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
CHUM Hôtel-Dieu
Montreal, Quebec, Canada
Clinique Specialisée en Allergie de la Capitale
Québec, , Canada
Rafael H Zaragoza-Urdaz
San Juan, , Puerto Rico
Countries
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References
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Zanichelli A, Wuillemin WA, Aygoren-Pursun E, Banerji A, Busse PJ, Betschel SD, Cancian M, Gagnon R, Goodyear MD, Kinaciyan T, Kessel A, Magerl M, Recke A, Wedner HJ, Estepan DN, Watt M, Andresen I, Juethner S, Khutoryansky N, Martinez-Saguer I. Lanadelumab's impact on hereditary angioedema control and quality of life across disease activity subgroups: Real-world evidence. Ann Allergy Asthma Immunol. 2025 Sep 5:S1081-1206(25)00393-X. doi: 10.1016/j.anai.2025.07.025. Online ahead of print.
Bernstein JA, Betschel SD, Busse PJ, Banerji A, Wedner HJ, Manning M, Zaragoza-Urdaz RH, Anderson J, Gagnon R, Baptist AP, Soteres D, Lumry WR, Craig T, Petroni D, Hsu FI, Nova Estepan D, Juethner S, Watt M, Khutoryansky N, Zuraw BL; EMPOWER Investigators. Sustained Effectiveness, Tolerability, and Safety of Long-Term Prophylaxis with Lanadelumab in Hereditary Angioedema: The Prospective, Phase 4, Noninterventional EMPOWER Real-World Study. Adv Ther. 2025 Aug;42(8):3882-3901. doi: 10.1007/s12325-025-03226-3. Epub 2025 Jun 12.
Tachdjian R, Banerji A, Busse PJ, Agmon-Levin N, Anderson J, Cancian M, Spadaro G, Enciu C, Estepan DN, Khutoryansky N, Jain S, Recke A. Effective long-term prophylaxis with lanadelumab in adolescents with hereditary angioedema: EMPOWER/ENABLE. Pediatr Allergy Immunol. 2025 Apr;36(4):e70072. doi: 10.1111/pai.70072.
Related Links
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To obtain more information on the study, click here/on this link
Other Identifiers
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TAK-743-403
Identifier Type: OTHER
Identifier Source: secondary_id
SHP643-403
Identifier Type: -
Identifier Source: org_study_id
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