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.

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这不一定是调查员的机构。 遗传性血管性水肿是一种不常见的遗传疾病，患者在皮肤下，肠壁，面部和生殖器的壁，手，脚和身体以及舌头和舌头和喉咙的肠壁有肿胀（血管性水肿）。 攻击可能随时发生，但已知它们与感染，牙科工作的创伤以及月经周期有关。 有些攻击没有已知原因。 当喉咙发生肿胀时，就有窒息的风险。 现在众所周知，肿胀至少部分归因于释放一种称为Bradykinin的化学物质。 这项研究的目的是研究一种被称为iCatibant的药物的安全性和有效性，该药物用其受体对体内细胞的受体阻断了脑力激素的作用。 在美国，没有FDA批准的药物来治疗遗传性血管性水肿的急性攻击。 我们知道，我们可以通过用雄性激素治疗许多患者的攻击频率。 许多患者，例如孕妇，年轻妇女和年龄较大的男性由于副作用而无法服用雄性激素。 该研究的目的是学习在体内封闭Bradykinin是否是治疗急性攻击时的安全和有益的方法。 该研究将在美国约15个中心进行，并将涉及约56例遗传性血管性水肿患者。 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性水肿的患者。