CompletedNot Applicable

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

United States168 participantsStarted 2019-03-30

Plain-language 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.

Who can participate

SexALL

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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.

What they're measuring

Number of Hereditary Angioedema (HAE) Attacks

Timeframe: From enrollment up to 36 months

Trial details

NCT IDNCT03845400

SponsorShire

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2022-10-22

View on ClinicalTrials.gov More Hereditary Angioedema (HAE) trials