CompletedNot Applicable

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

Austria, Germany, Israel140 participantsStarted 2019-12-11

Plain-language summary

The main aim of this study is to compare the number of HAE attacks occuring in persons using lanadelumab with the number of HAE attacks before lanadelumab treatment was started. Data from participants who start the study after 1 March 2021, will be collected for 24 months; data from all other participants (who started the study before 1 March 2021) will be collected for 36 months. Participants will report information in a smartphone application at study start and for the next 3 months and then every 6 months until the study ends; data will also be collected by the study doctor during routine clinic visits

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Voluntarily provision of written, signed, and dated (personally or via a legally authorized representative) informed consent to participate in the study. * Initiation of treatment with lanadelumab in accordance with current product labelling. Decision to start treatment with lanadelumab must be made before and be independent from enrollment in the study. * Availability of information for HAE attack-related variables assessed at study enrollment for the previous three months. * Ability to use a smartphone for data collection in this study. Exclusion Criteria: * Inability to provide written, signed, and dated informed consent. * Participation in the study not considered appropriate by the treating physician/investigator. * Contraindication to treatment with lanadelumab according to current product labelling. * Pregnant or breastfeeding. * Concomitant exposure to any investigational therapy (including medications not used for HAE). * Current or planned participation in other interventional studies.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence Rate Ratio of On-Treatment Participant-Reported Hereditary Angioedema (HAE) Attacks

Timeframe: Up to 36 months

Trial details

NCT IDNCT04130191

SponsorShire

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2024-09-09

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

Plain-language summary

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.