Active not recruitingPHASE3INTERVENTIONAL

PK Subtrial in Adolescent Patients With HAE Type I or II Participating in the KVD900-302 Trial

This study is looking for teenagers aged 12 to 17 who have a rare condition called Hereditary Angioedema (HAE) types 1 or 2. These young people must already be taking part in a different study for the medicine KVD900. The main goal of this new study is to see how the body processes the KVD900 medicine. This is important information to gather because it helps doctors understand how the drug works in younger people and ensures the right dose is given. By looking closely at how KVD900 moves through and leaves their bodies, researchers can make better decisions about using this medicine safely and effectively for teenagers with HAE. It's a key step in learning more about this important treatment.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

KalVista Pharmaceuticals, Ltd.

Enrolment target

Start

24 Oct 2022

Estimated completion

30 Jun 2026

Hereditary Angioedema

What is this study about?

This research study is for young people between 12 and 17 years old who have a condition called Hereditary Angioedema (HAE) type 1 or 2. HAE is a rare genetic condition that causes sudden, painful swelling attacks in different parts of the body. If you or your child have HAE, you might already be familiar with treatments to prevent or stop these attacks.

This particular study is focusing on a medicine called KVD900. It's designed for young people who are already taking part in another study (called KVD900-302) that is also looking at this medicine. The main aim here is to understand how your body handles KVD900 – how it's absorbed, where it goes, and how it leaves your system. This is often called studying the 'PK profile' of a drug.

Why does this matter? Children and teenagers are still growing and developing, so their bodies can process medicines differently compared to adults. By understanding how KVD900 works specifically in young people aged 12-17, doctors can make sure they recommend the safest and most effective dose for this age group. It helps ensure that children get the right amount of medicine to manage their HAE without unnecessary side effects.

Key takeaways

The study is for young people (12-17 years old) with HAE types 1 or 2.
You must already be in the KVD900-302 study.
It helps doctors understand how KVD900 works in teenagers' bodies.
Participation involves giving extra samples (like blood) and keeping an electronic diary.
It cannot be joined if you have bleeding disorders or take blood thinners.

Who may be eligible?

This study is looking for young people who fit a very specific description. First, you must be between 12 and 17 years old when you start the study and throughout the time samples are collected. It's open to both boys and girls.

You also need to already be involved in a larger study called KVD900-302. This means that if you're not currently part of that study, you won't be able to join this one. Both you (if old enough to understand) and your parent or legal guardian will need to agree to take part and sign some consent forms.

It's important that you and your guardian are willing and able to collect samples, like blood samples, as requested by the study, and that you're comfortable using an electronic diary to record information. You won't be able to join if you have any history of bleeding problems or if you're currently taking medicines that thin the blood, like anticoagulants or anti-platelet drugs.

Quick self-check

Am I between 12 and 17 years old?
Do I have Hereditary Angioedema (HAE) type 1 or 2?
Am I already taking part in a study called KVD900-302?
Am I willing to provide samples and use an electronic diary?
Do I have any bleeding disorders or take blood-thinning medication?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, you'll need to continue with your current KVD900 treatment as part of the KVD900-302 study. This new sub-study involves collecting additional samples, likely blood samples, at specific times to see how the KVD900 medicine is moving through your body. You'll be asked to record information in an electronic diary, which helps the researchers track your progress and any effects of the medication. The study team will explain exactly when and how these samples will be collected and how often you'll need to use the diary. They'll also explain what follow-up appointments might be needed. The total duration of your participation in this sub-study will be explained fully by the study team, but it's linked to your ongoing participation in the main KVD900-302 trial.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of joining this study is that it helps doctors better understand how KVD900 works in young people with HAE. This knowledge can lead to improved treatment plans and safer dosing guidelines for teenagers with your condition in the future. As for risks, blood draws might cause some temporary discomfort, bruising, or rarely, a minor infection. You might also find the extra sample collections and diary entries a bit time-consuming. It's important to remember that you are free to leave the study at any time, for any reason, without it affecting your medical care.

Locations (61)

KalVista Investigative Site
Scottsdale, United States
KalVista Investigative Site
Little Rock, United States
KalVista Investigative Site
San Diego, United States
KalVista Investigative Site
San Diego, United States
KalVista Investigative Site
Santa Monica, United States
KalVista Investigative Site
Centennial, United States
KalVista Investigative Site
Colorado Springs, United States
KalVista Investigative Site
Evansville, United States
KalVista Investigative Site
Overland Park, United States
KalVista Investigative Site
Louisville, United States
KalVista Investigative Site
Chevy Chase, United States
KalVista Investigative Site
Plymouth, United States

+49 more sites — see the official record for the full list.

Common questions

What is KVD900?

KVD900 is a medicine being tested for treating Hereditary Angioedema (HAE), a condition that causes swelling attacks.

What does 'PK profile' mean?

'PK profile' is a way for doctors to describe how a medicine moves through your body, how long it stays there, and how it leaves.

Do I have to be in another study first?

Yes, to be in this study, you must already be participating in the KVD900-302 study.

Will I get paid to be in the study?

The study information doesn't mention payment. This is a good question to ask the study team if you're interested in joining.

What is Hereditary Angioedema (HAE)?

HAE is a rare inherited condition that causes sudden, repeated attacks of swelling in different parts of the body, like the face, hands, feet, or tummy.