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.

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。 大约50例受试者将在美国至少3家治疗中心入组。本研究预计持续约12个月，受试者将积极参与28周，其中24周为治疗期和末次治疗后4周的随访期。试验将包括两个子集。在第一项研究中，所有受试者将被随机分配接受Kamada-API或Prolastin（2：1）每周一次输注。也就是说，对于每两名随机选择接受Kamada-API的受试者，将随机选择一名接受Prolastin。 签署知情同意书后，将进行筛选程序，包括生命体征、病史、体格检查、血液学和生化分析以及病毒学抽血。如适用，目前接受API治疗的受试者将接受5周洗脱期，在此期间他们将不接受API。将纳入至少6例受试者。