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

Completed

Conditions studied: Hereditary Angioedema (HAE)

In brief

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.

Key facts

Study ID

NCT03845400

Run by

Shire

People needed

168

Starts

2019-03-30

Expected to finish

2022-10-22

Last updated by the study team

2023-03-30

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.