CLINICAL TRIAL: KAMADA-API

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 大约50名受试者将在美国至少3个治疗中心登记。这项研究预计需要大约12个月，受试者将积极参与28周，其中24周为治疗期，并在最终治疗后4周进行随访期。试验将包括两个子集。在第一项试验中，所有受试者将被随机分配，以2：1的方式每周接受Kamada-API或Prolastin的输注。也就是说，每随机选择两名受试者接受Kamada-API治疗，将随机选择一名接受Prolastin治疗。签署知情同意书后，将进行筛查程序，包括生命体征、病史、体检、血液学和生化分析以及病毒学抽血。如果适用，目前正在接受原料药治疗的受试者将经历5周的洗涤期，在此期间他们将不接受原料药。将包括至少6个科目。

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.