If you have been diagnosed with HAE, you may qualify to join the RAPIDe-1 clinical research study for people with hereditary angioedema (HAE).
The study drug, PHVS416, is an investigational drug designed to block the compound bradykinin and potentially stop an HAE attack before it gets too severe. Investigational means that the study drug has not been approved by the regulatory authority in any country to be used for attacks caused by HAE.
There are approved medications for resolving HAE attacks. However, these must be injected either into a vein or under the skin, whereas the study drug is a soft capsule taken by mouth.
Should you choose to participate, you will be assigned at random (like a coin flip) to receive a low, medium, or high dose of the study drug. For each attack you will take a total of 3 soft capsules. If the capsules you take have no effect, you will be allowed to use an approved HAE medication to resolve the attack. This will be called “rescue medication”. You will receive proper instructions in this respect.
The study drug will be compared to a placebo. A placebo is an inactive substance that looks just like the study drug. If you take part in this clinical research study, you will take capsules to treat a total of 3 HAE attacks. The capsules will be organized so that 2 of the HAE attacks will be treated with study drug, and 1 will be treated with placebo.
If you meet the study requirements and decide to participate, your participation will last up to 7 months, and you will attend 5 study visits at the study location. Between study visits, you will record information daily in a study-provided electronic diary, and during attacks, you will use the diary to answer several questions about your symptoms. You will also have regular phone contact with your study doctor during HAE attacks.
Participation will last up to approximately 7 months, and you can expect the following:
Attend 5 study visits at the study location for study tests and procedures.
Be assigned at random (like a coin flip) to receive a low, medium, or high dose of the study drug.
Regular phone contacts with your study doctor during HAE attacks.
If the study capsules you take have no effect, you will be allowed to use an approved HAE medication to resolve the attack.
Use a study-provided electronic diary daily and more frequently during HAE attacks to answer questions about your symptoms. (training will be provided)
Choose Your Country | Choisissez votre pays | Wähle dein Land | Válassza ki az országot | Scegliere il proprio Paese
Kies uw land | Wybierz swój kraj | Seleccione su país | Vyberte svou zemi | Изберете Вашата държава | Выберите Вашу страну | בחר/י את מדינתך | اختر دولتك