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A Study of Lanadelumab in Persons With Hereditary Angioedema (HAE) Type I or II in North America | Clinical Trials | Clareo Health

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

An Observational, Non-interventional, Study of Patients With Hereditary Angioedema in the United States and Canada (EMPOWER Study)

NCT03845400•Shire

View on ClinicalTrials.gov

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 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.

Eligibility

Age

All ages

Sex

ALL

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.

Locations (29)

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

Key Dates

Start Date

March 30, 2019

Primary Completion Date

October 22, 2022

Completion Date

October 22, 2022

Last Updated

March 30, 2023

Enrollment

168

ACTUAL participants

Conditions

Hereditary Angioedema (HAE)

Donidalorsen Treatment in Children With Hereditary Angioedema

NCT07298447

Hereditary Angioedema (HAE)

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RECRUITINGPHASE3

A Study of Navenibart in Participants With Hereditary Angioedema

NCT06842823

Hereditary Angioedema (HAE)

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ACTIVE_NOT_RECRUITING

A Study of Lanadelumab in Teenagers and Adults With Hereditary Angioedema (HAE)

NCT05469789

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 30, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Donidalorsen Treatment in Children With Hereditary Angioedema

A Study of Navenibart in Participants With Hereditary Angioedema

A Study of Lanadelumab in Teenagers and Adults With Hereditary Angioedema (HAE)

Phase 3 Extension Study of ADX-324 in Participants With Hereditary Angioedema (HAE)

CSL312_3003 Safety and Pharmacokinetic Study in Subjects 2 to 11 Years of Age With Hereditary Angioedema

A Study to Explore Hereditary Angioedema (HAE) Symptoms and Treatment Patterns in Korean People