SUBCUTANEOUS FORMULATION OF ICATIBANT FOR THE TREATMENT OF HEREDITARY ANGIOEDEMA

点击翻译按钮获取中文摘要

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Hereditary angioedema is an uncommon genetic disease in which patients have attacks of swelling (angioedema) under the skin, in the wall of the intestine, of the face and genitalia, of the hands, feet, and body and of the tongue and throat. The attacks may occur at any time, but they are known to be associated with infections, the trauma of dental work and with the menstrual cycle. Some attacks have no known cause. When the swelling occurs in the throat there is a risk of suffocation. It is now known that the swelling is due, at least in part, to release of a chemical known as bradykinin. The purpose of this research study is to study the safety and effectiveness of a drug known as Icatibant that blocks the action of the bradykinin with its receptor on cells in the body. In the United States, there are no FDA approved drugs for treatment of the acute attacks of hereditary angioedema. We know that we can reduce the frequency of attacks in many patients by treating them with male hormones. Many patients, such as pregnant women, young women and older men cannot take male hormones because of the side effects. The purpose of the research is to learn if blocking of bradykinin in the body is a safe and beneficial way to treat acute attacks when they occur. The study will be done in about 15 centers in the United States and will involve about 56 patients with hereditary angioedema. Eventually, the information gained from the study could be used to get approval of Icatibant for treatment of patients with hereditary angioedema.