Active not recruitingOBSERVATIONAL

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

This study is for teenagers and adults in the UK who have a rare condition called Hereditary Angioedema (HAE) where they get sudden swelling attacks. It’s looking at how a medicine called lanadelumab affects these attacks. Researchers want to compare how many attacks people had in the year before they started lanadelumab with how many they have for up to two years after starting it. This will help doctors understand how well lanadelumab helps to reduce HAE attacks, including those that need immediate treatment. Information for the study will come from participants' medical records, diaries, and questionnaires, and they'll be contacted every three months by phone.

At a glance

Status

Active not recruiting

Sponsor

Takeda

Enrolment target

Start

29 Jun 2023

Estimated completion

31 Dec 2026

Hereditary Angioedema (HAE)

What is this study about?

This research study is about a medicine called lanadelumab, which is used to treat a condition known as Hereditary Angioedema, or HAE. HAE is a rare genetic condition that causes sudden, painful swelling attacks in various parts of the body, like the hands, feet, face, and airways. These attacks can be very disruptive and sometimes dangerous.

The main goal of this study is to understand how well lanadelumab helps people manage their HAE. Specifically, the researchers want to compare the number of HAE attacks people have in the 12 months before they start taking lanadelumab with the number of attacks they have for up to two years after they begin treatment. They're also interested in seeing if the number of attacks that need urgent treatment changes.

This study is being carried out in the UK and involves people who are already receiving lanadelumab as part of their regular care from their hospital doctors, or who are about to start it. By collecting information directly from participants, their medical records, and their doctors, the study hopes to provide clear evidence on the real-world benefits of lanadelumab for HAE patients.

Key takeaways

This study looks at how a current HAE medicine, lanadelumab, works in real life.
It aims to understand if lanadelumab reduces HAE attacks over time.
Data will be collected from existing medical records, diaries, and phone calls.
You must be 12 years or older and already on (or starting soon) lanadelumab.
Participation involves sharing information, not trying new treatments.

Who may be eligible?

To join this study, you need to have a confirmed diagnosis of Hereditary Angioedema (HAE) type I or II, which means it's been properly identified through lab tests. You also need to be 12 years old or older when you start taking lanadelumab, and you must either be already taking lanadelumab or be scheduled to start it within the next four weeks.

Another important point is that your medical records must show at least 12 continuous months of information about your HAE before you started taking lanadelumab. This allows the researchers to compare your HAE attacks before and after starting the medicine.

You cannot be included in this study if you have ever received lanadelumab as part of another research study or clinical trial in the past.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Do I have a confirmed diagnosis of HAE Type I or II?
Am I 12 years old or older?
Am I currently taking lanadelumab or due to start it within the next 4 weeks?
Do my medical records have at least 12 months of information about my HAE before I started (or start) lanadelumab?
Have I never taken lanadelumab in another research study before?

Answer every question to see your result.

What does participation involve?

If you take part in this study, the researchers will collect information about your health and your HAE attacks. This information will come from several sources, including your hospital medical records, questionnaires you fill out, and a diary where you can record your HAE attacks. Your study doctors will also provide information.

You won't have any extra visits to the hospital specifically for this study. Instead, the researchers will contact you every three months by phone to follow up and collect information. The study will look at your health for up to 24 months (two years) after you start taking lanadelumab alongside your usual visits with your HAE care team.

Potential risks and benefits

This study doesn't involve giving you new medicines or treatments; it's about watching how lanadelumab, which you're already receiving or about to receive as part of your normal care, works for you. The main benefit is helping to gather important information that can improve the understanding and treatment of HAE for everyone. Since you are already taking lanadelumab as part of your routine care, there aren't additional medical risks directly from participating in this observation study. The main commitment is providing information through diaries and questionnaires and having phone check-ins every three months. You are free to withdraw from the study at any time without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Barts Health NHS Trust
Verified postcode
London, United Kingdom

Common questions

What is Hereditary Angioedema (HAE)?

HAE is a rare condition that causes unexpected and painful swelling attacks in the body.

What is lanadelumab?

Lanadelumab is a medicine used to help prevent or reduce swelling attacks in people with HAE.

Will I have to take a new medicine if I join?

No, this study is for people already using or about to start lanadelumab as part of their regular care, not for trying new medicines.

How often will I be contacted for the study?

The study team will contact you every three months by phone to gather information.

Will joining this study change my regular HAE treatment?

No, joining this study will not change how your HAE is treated by your doctors.

How to find out more

Official trial record

Always speak to your GP or specialist before deciding to take part in a study.