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: 7604445
• 负责人: CHARLES HARVEY KIRKPATRICK
• 金额: $ 0.24万
• 依托单位: UNIVERSITY OF COLORADO DENVER
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-07-01 至 2008-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7604445
• 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.

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 遗传性血管性水肿是一种罕见的遗传性疾病，患者在皮肤下、肠壁、面部和生殖器、手、脚和身体以及舌头和喉咙的肿胀（血管性水肿）发作。 这些攻击可能发生在任何时候，但它们被认为与感染，牙科工作的创伤和月经周期有关。 有些攻击没有已知的原因。 当肿胀发生在喉咙有窒息的危险。 现在我们知道，肿胀至少部分是由于一种叫做缓激肽的化学物质的释放。 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，没有FDA批准的药物用于治疗遗传性血管性水肿的急性发作。 我们知道，我们可以通过男性激素治疗来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男性激素。 这项研究的目的是了解在体内阻断缓激肽是否是治疗急性发作的安全和有益的方法。 这项研究将在美国的大约15个中心进行，涉及大约56名遗传性血管性水肿患者。 最终，从研究中获得的信息可以用于批准Icatibant治疗遗传性血管性水肿患者。