Frequently Asked Questions (FAQs)
What is the purpose of the KOMPLETE Study?
The purpose of the KOMPLETE Study is to understand the effects of an investigational oral medication called KVD824. Three different doses will be studied to see which one may be best as a safe prophylaxis treatment for HAE attacks.
Who can take part in the KOMPLETE Study?
The KOMPLETE Study is for adults 18 years of age and older with a confirmed diagnosis of HAE type I or type II.
How long is the KOMPLETE Study?
The study will last approximately 32 weeks with up to 7 visits depending on your region. Your doctor will provide more details at your first visit. If you qualify, the Treatment Period will last approximately 12 weeks.
What will be expected of me during the study?
You will be expected to attend all study visits and take the study medication as instructed. If selected to participate, the study staff will provide you with the full list of instructions and explanation of what will happen at each visit.
What treatment will I receive during the study?
You will be placed by chance in a treatment group to receive one of three doses of the study medication or placebo. If the study medication does not prevent an attack, you may treat it with an approved HAE treatment agreed upon with your study doctor.
How is the study drug taken?
The study medication is a tablet that you take by mouth. You will take the study medication by mouth two times a day (about every 12 hours) with your morning and evening meals.
What kind of tests will I have during the study?
At study visits, you will have tests and health checks, including blood tests, an electrocardiogram (ECG) to measure your heart’s electrical activity, and a physical exam. You will also have your vital signs taken, which include your pulse, breathing rate, and blood pressure.
What information will I need to enter in the electronic diary?
You will use the diary provided to you to answer questions about how HAE affects your everyday life and to keep track of your study medication dosing and of any HAE attacks you may have.
What are the benefits of being in a clinical research study?
You may or may not directly benefit from being in a clinical study. However, the information collected during the KOMPLETE Study may help doctors learn more about the study medication and HAE, which may help others with HAE in the future.
Do I have to pay any study costs?
Taking part in this study will not cost you anything. You may be able to get reimbursed for your travel expenses to and from the study site.
What kind of support will I receive during the study?
A support service may be available, depending on your region, to offer you non-medical support and guidance during the study. This service will provide travel arrangements to and from the study site if you need help getting to your visits. This is an optional service and you may opt out at any time. The service is included at no cost to you.
To learn more about the KOMPLETE Study, and to find a study site near you, call (877) 223-3576, and use code: 25885.