SUBCUTANEOUS FORMULATION OF ICATIBANT FOR THE TREATMENT OF HEREDITARY ANGIOEDEMA

用于治疗遗传性血管性水肿的 Icatibant 皮下制剂

• 批准号: 7719495
• 负责人: CHARLES HARVEY KIRKPATRICK
• 金额: $ 0.03万
• 依托单位: UNIVERSITY OF COLORADO DENVER
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-04-01 至 2008-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7719495
• 关键词: Acute; Adverse effects; Angioneurotic Edema; Asphyxia; Bradykinin; Cells; Chemicals; Computer Retrieval of Information on Scientific Projects Database; Dental; Drug Formulations; Effectiveness; Face; Frequencies; Funding; Genitalia; Grant; Hand; Hereditary Disease; Hormones; Infection; Institution; Intestines; Learning; Menstrual cycle; Patients; Pharmaceutical Preparations; Pharyngeal structure; Pregnant Women; Purpose; Research; Research Personnel; Resources; Risk; Safety; Skin; Source; Swelling; Time; Tongue; Trauma; United States; United States Food and Drug Administration; United States National Institutes of Health; Woman; Work; foot; hereditary angioneurotic edema; icatibant; male; older men; receptor; research study; subcutaneous

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.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目及 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 遗传性血管性水肿是一种罕见的遗传性疾病，患者会出现皮下、肠壁、面部和生殖器、手、脚、身体以及舌头和喉咙的肿胀（血管性水肿）。 这些发作可能随时发生，但已知它们与感染、牙科手术创伤和月经周期有关。 有些攻击的原因不明。 当喉咙肿胀时，有窒息的危险。 现在已知，肿胀至少部分是由于一种称为缓激肽的化学物质的释放造成的。 这项研究的目的是研究一种名为 Icatibant 的药物的安全性和有效性，该药物可阻断缓激肽及其受体对体内细胞的作用。 在美国，尚无 FDA 批准的药物用于治疗遗传性血管性水肿急性发作。 我们知道，通过使用雄性激素治疗，可以减少许多患者的发作频率。 许多患者，如孕妇、年轻女性和老年男性，由于副作用而不能服用雄性激素。 该研究的目的是了解体内阻断缓激肽是否是治疗急性发作时安全且有益的方法。 该研究将在美国约 15 个中心进行，涉及约 56 名遗传性血管水肿患者。 最终，从研究中获得的信息可用于批准 Icatibant 用于治疗遗传性血管水肿患者。