KalVista Study for Hereditary Angioedema
Hereditary Angioedema (HAE) is a rare genetic condition that involves recurrent attacks of severe swelling in various parts of the body. Although there is no existing cure for HAE, research is underway on an investigational medication option for adolescents and adults 12 years or older.
The KONFIDENT Study is a clinical research study of an oral on-demand treatment for adolescents and adults with HAE type I or type II. The purpose of the KONFIDENT Study is to understand the effects of an investigational oral medication called KVD900, that works by inhibiting plasma kallikrein, which reduces swelling and may help to relieve symptoms of an HAE attack. Doctors are studying 2 different doses to see which one may be best as a safe on-demand treatment for HAE attacks.
Who can take part in the study?
You may be able to participate if:
- You are 12 years of age and older
- You have a confirmed diagnosis of HAE type I or type II
- You have access to and are able to use on-demand medication for HAE attacks
- You have had at least 2 HAE attacks in the last 3 months
- You are willing to attend all study visits
- You are willing to provide information about your HAE attacks in an electronic diary
- You are willing to use a study-approved method for birth control during the study
Patient Commitment Duration:
The KONFIDENT Study lasts approximately 25 weeks with 6 visits or televisits (phone call or video chat) for health checks and tests at no cost to you.
If you join this study, you will treat 3 HAE attacks, with either 300mg or 600mg of KVD900 or placebo, in a random order. The placebo looks like KVD900 but does not have medicine in it. This helps the researchers to better understand the effects of KVD900.
Electronic Diary (eDiary):
Interested in taking part in a clinical trial?
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Interested in Other Enrolling Clinical Trials?
All of our studies are regulated by the Food and Drug Administration (FDA). To find out more, click on the links below.