The purpose of the KONFIDENT Study is to understand the effects of an investigational oral medication called KVD900. Two different doses will be studied to see which one may be best as a safe on-demand medication for HAE attacks.
Who can take part in the KONFIDENT Study?
The KONFIDENT Study is for adolescents and adults (12 years of age and older) with a confirmed diagnosis of HAE type I or type II.
How long is the KONFIDENT Study?
You will be in the study for approximately 25 weeks with 6 visits or televisits for health checks and tests. This study is divided into a screening period (up to 4 weeks), a treatment period (treatment of 3 eligible HAE attacks with televisits after each attack), and a final study visit.
What will be expected of me during the study?
You will be expected to attend all study visits (over the phone or video chat), provide information about your HAE attacks in an electronic diary, and take the study medication as instructed for eligible attacks. You will be expected to call to receive dosing instruction information. If you are selected to participate, the study staff will provide you with more information about what you need to do during the study.
What treatment will I receive during the study?
Each participant will receive enough study medication to treat 3 separate eligible HAE attacks, including 2 different doses of KVD900 and placebo. The placebo looks like KVD900 but does not have medicine in it.
How is the study medication taken?
The study medication is a tablet that you take by mouth. For each eligible HAE attack, you will take the medication as instructed as soon as possible after the start of the attack.
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 an electronic diary to answer questions about your HAE attacks and how you feel. The diary will confirm if you can use the study medication to treat your attack or if you should use your on-demand medication. You will also rate your symptoms and the severity of each attack before and after treatment with the study medication.
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 KONFIDENT Study may help doctors learn more about KVD900 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.
To learn more about the KONFIDENT Study, and to find a study site near you, call (877) 223-3576, and use code: 54478
