CLINICAL TRIAL: PHASE II STUDY OF THE SAFETY & EFFICACY OF RECOMBINANT HUMAN C1

临床试验：第二阶段安全性研究

• 批准号: 7950979
• 负责人: Bruce L. Zuraw
• 金额: $ 0.06万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN DIEGO
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-12-01 至 2009-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7950979
• 关键词: Acute; Clinical Research; Complement component C1s; Computer Retrieval of Information on Scientific Projects Database; Drug Kinetics; Funding; Grant; Human; Institution; Patients; Pharmacodynamics; Phase II Clinical Trials; Recombinants; Research; Research Personnel; Resources; Safety; Source; United States National Institutes of Health; safety study

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. Assess the safety and tolerability of rhC1INH in symptomatic patients with HAE. Demonstrate the efficiacy of rhC1INH in the treatment of acute attacks in patients with HAE. Assess the pharmacokinetics (PK) and pharmacodynamics (PD) of rhC1INH in symptomatic patinets with HAE. Assess the safety, tolerability and effects of rhC1INH in treating subsequent attacks of HAE.

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。 评估RHC1INH在有症状的HAE患者中的安全性和耐受性。 证明RHC1INH对HAE患者的急性攻击的效率。 在具有HAE的有症状性patinets中，评估RHC1INH的药代动力学（PK）和药效学（PD）。 评估RHC1INH在治疗HAE的后续攻击中的安全性，耐受性和影响。