CLINICAL TRIAL: KAMADA-API

临床试验：Kamada-API

• 批准号: 7950746
• 负责人: MARK Louis BRANTLY
• 金额: $ 0.36万
• 依托单位: UNIVERSITY OF FLORIDA
• 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 2009-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7950746
• 关键词: Biochemical; Blood; Clinical Research; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Enrollment; Funding; Grant; Informed Consent; Infusion procedures; Institution; Medical History; Physical Examination; Prolastin; Randomized; Research; Research Personnel; Resources; Screening procedure; Source; United States National Institutes of Health; follow-up; microbial alkaline proteinase inhibitor; treatment center; treatment duration; virology

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. Approximately 50 subjects will be enrolled in at least 3 treatment centers in the US. This study is expected to take about 12 months and the subjects will be actively involved for 28 weeks out of which 24 weeks are treatment period and a follow up period which occurs 4 weeks after the final treatment. The trial will include two subsets. In the first one, all subjects will be randomly assigned to receive weekly infusions of either the Kamada-API or Prolastin in a 2 to 1 fashion. That is for every two subjects randomly selected to receive Kamada-API one will be randomly selected to receive Prolastin. Following signing of an informed consent, screening procedures will be done, including vitals signs, medical history, physical examination, hematological and biochemical analyses, and virology blood draws. If applicable, subjects currently on API therapy will undergo a 5-week washout period during which they will receive no API. At least 6 subjects will be included.

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。 在美国，至少3个治疗中心将招募大约50名受试者。预计这项研究将需要大约12个月的时间，并且受试者将积极参与28周，其中24周是治疗期，并且在最终治疗后4周发生的随访期。试验将包括两个子集。在第一个中，所有受试者将被随机分配，以2比1的方式每周接收Kamada-Api或Prolastin的每周输注。那是每两个主题随机选择接收卡玛达 - API的主题，将随机选择接收prolastin。 在签署知情同意书后，将进行筛查程序，包括生命症状，病史，体格检查，血液学和生化分析以及抽血。如果适用，目前正在接受API治疗的受试者将经历5周的冲洗期，在此期间他们将不接受API。至少将包括6个主题。