A clinical research study of an oral on-demand treatment for adolescents and adults with Hereditary Angioedema (HAE) type I or type II

Purpose of the KONFIDENT Study

The purpose of the KONFIDENT Study is to understand the effects of an investigational oral medication called KVD900 in adolescents and adults (12 years of age and older) with HAE type I or type II. Doctors are studying 2 different doses to see which one may be best as a safe on-demand treatment for HAE attacks.

About KVD900

KVD900 is an investigational oral medication designed to treat HAE attacks. It works by inhibiting plasma kallikrein, which reduces swelling and may help to relieve symptoms of an HAE attack. KVD900 is a tablet that is taken by mouth after an attack has started.

Who can participate in this 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

What to expect during the study

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)

You will use an electronic diary to answer questions about your HAE attacks and to determine if you should treat the attack using the study medication or your regular on-demand medication.

Taking the study medication

The study medication comes as tablets to be taken by mouth. You will receive enough study medication to treat 3 separate, eligible HAE attacks. Take the study medication provided to you as soon as possible after the start of the attack.

Each time you take the study medication, you will have a televisit (phone call or video chat) with your study doctor or study staff to see how you are feeling and to go over the information in your diary.
You will be monitored continuously throughout the study for any changes in health or potential side effects.

To learn more about the KONFIDENT Study, and to find a study site near you, call (877) 223-3576, and use code: 54478

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