An Open-label Extension Trial to Evaluate the Long-term Safety of KVD900, an Oral Plasma Kallikrein Inhibitor, for On-demand Treatment of Angioedema Attacks in Adolescent and Adult Patients with Hereditary Angioedema Type I or II A Pharmacokinetic Subtrial in Adolescent Patients with Hereditary Angioedema Type I or II Participating in the KVD900-302 Trial
This research is an ongoing study to see how safe a new medicine, KVD900, is when taken over a longer period. KVD900 is a tablet designed to treat sudden swelling attacks in people who have a condition called Hereditary Angioedema (HAE) Type 1 or 2. The study involves both adults and teenagers. For teenagers specifically, the researchers are also looking at how their bodies process the medicine. The main goal is to keep an eye on any side effects and understand how patients are generally doing while taking KVD900 for their HAE attacks.
At a glance
What is this study about?
This study is about a medicine called KVD900, which is being tested for people who have a condition called Hereditary Angioedema (HAE) Type 1 or 2. HAE is a rare genetic condition that causes sudden and unpredictable swelling in different parts of the body, such as the face, hands, feet, tummy, or airways, which can be very painful and sometimes dangerous.
The medicine, KVD900, is an oral tablet, meaning you take it by mouth. It's designed to be used "on-demand" – so when you feel an HAE attack starting. This study is an "open-label extension trial," which means that everyone taking part knows they are receiving the actual study medicine, KVD900. It's an extension because it allows people who have been in previous studies with KVD900 to continue taking it for a longer time.
The main purpose of this study is to closely monitor the safety of KVD900 over a longer period. The researchers want to see if there are any side effects, how often they occur, and if anyone needs to stop taking the medicine because of them. They will also be checking blood test results and general health signs like blood pressure regularly. For teenagers specifically, there's an additional part of the study (called a "subtrial") to understand how their bodies handle and use the medicine.
Key takeaways
- This study is testing the long-term safety of KVD900 for HAE Type 1 or 2.
- KVD900 is a tablet taken at the start of an HAE swelling attack.
- It's an extension study for people previously in KVD900 trials.
- Researchers will monitor side effects and overall health.
- Teenagers will have extra checks to see how their bodies handle the medicine.
- Participation involves regular visits and health assessments.
Who may be eligible?
To be part of this study, you generally need to be an adult, aged 18 years or older. There might be some specific requirements for teenagers due to the additional part of the study focused on how young bodies process the medicine.
Since this is an "extension" study, it means that you would typically have already taken part in an earlier study for KVD900. This helps the researchers continue to gather long-term information on people who are already familiar with the medicine.
Both males and females can take part. The most important health requirement is that you must have been diagnosed with Hereditary Angioedema Type 1 or Type 2. The study team will check your full medical history and current health to make sure it's safe for you to join.
- Are you 18 years old or older? (Or a teenager specifically asked to join the adolescent subtrial?)
- Have you been diagnosed with Hereditary Angioedema Type 1 or Type 2?
- Have you previously taken part in a KVD900 study?
- Are you able to attend regular study visits and follow instructions?
- Are you willing to take the study medicine as directed?
- Are you comfortable with blood tests and physical examinations?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you join this study, you would continue to take the study medicine, KVD900, by mouth when you experience an HAE attack. You would have regular check-ups with the study team. These visits will involve various assessments, including physical examinations, blood tests, and checking your vital signs like blood pressure and heart rate. These checks help the researchers understand how you are responding to the medicine and if there are any safety concerns.
You would also be asked to keep track of your HAE attacks and how well the medicine works for you. The study will look at how quickly your symptoms improve after taking KVD900. The total duration of your participation would depend on the study plan, but because it's an extension study, it's designed to gather long-term information.
Potential risks and benefits
Locations (13)
- —Slovakia
- —Netherlands
- —Italy
- —Bulgaria
- —Hungary
- —Austria
- —Germany
- —Greece
- —Poland
- —Romania
- —France
- —Spain
+1 more sites — see the official record for the full list.
Common questions
What is Hereditary Angioedema (HAE)?
HAE is a rare condition that causes sudden swelling in different parts of your body, which can be painful and sometimes serious.
What is KVD900?
KVD900 is an investigational medicine in tablet form, being studied to treat HAE swelling attacks when they happen.
Is this medicine available to everyone?
No, KVD900 is currently a study medicine and is not yet available as a standard treatment.
Why is this an 'extension' study?
It means people who were in earlier KVD900 studies can continue taking the medicine to gather more information on its long-term safety.
Will I know if I'm getting the real medicine?
Yes, this is an 'open-label' study, so everyone involved knows they are receiving KVD900.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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