CompletedNot Applicable

A Study in Teenagers and Adults With Hereditary Angioedema (HAE) Type I or Type II Who Use Lanadelumab as Long-Term Prophylaxis

Austria, France, Germany207 participantsStarted 2021-09-15

Plain-language summary

The main aims of this study are to learn how many people with HAE Type I or Type II are attack-free when treated with lanadelumab in real life. This includes the number of people that are attack-free when lanadelumab is given every 2 and every 4 weeks. This study is about collecting existing data only; participants will not receive lanadelumab as part of this study. No new information will be collected during this study. Only data already available at the participant's doctor's office will be reviewed and collected for this study. Participants do not need to visit their doctor in addition to their normal visits.

Who can participate

Age range

12 Years

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: * Participant is aged \>= 12 years at the time of the last documented HAE attack in the eligibility period. * Participant has a physician-confirmed diagnosis (or confirmation in medical records) of HAE type I or type II. * Participant had initiated LTP with lanadelumab during the eligibility period. * Participant provides informed consent or assent prior to the initiation of any study procedures (where required by local regulations). Exclusion Criteria: * Participant was enrolled in a therapeutic investigational drug or device trial during the observation period. * Participant without documented HAE attacks in the pre-index period and/or without available participant diary or systematic documentation of HAE attacks in the medical records during the post index period.

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

Percentage of Participants Who Are Free of Hereditary Angioedema (HAE) Attacks Treated With Lanadelumab

Timeframe: Up to Month 12

Percentage of Participants Who Are Free of HAE Attacks Treated With Lanadelumab Administered Every Two Weeks

Timeframe: Up to Month 12

Percentage of Participants Who Are Free of HAE Attacks Treated With Lanadelumab Administered Every Four Weeks

Timeframe: Up to Month 12

Trial details

NCT IDNCT04861090

SponsorTakeda

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2022-06-30

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

Plain-language summary

Who can participate

Age range

12 Years

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.

What they're measuring

Percentage of Participants Who Are Free of Hereditary Angioedema (HAE) Attacks Treated With Lanadelumab

Timeframe: Up to Month 12

Percentage of Participants Who Are Free of HAE Attacks Treated With Lanadelumab Administered Every Two Weeks

Timeframe: Up to Month 12

Percentage of Participants Who Are Free of HAE Attacks Treated With Lanadelumab Administered Every Four Weeks

Timeframe: Up to Month 12