CLINICAL TRIAL: CHAMP

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。 在这项临床研究中，一种通过改进制造工艺生产的血浆衍生的阿尔法1-蛋白水解酶抑制物产品将被用作成人甲型抗胰蛋白酶缺乏症患者和相关破坏性肺部疾病的强化疗法。这项多中心的第三阶段研究将在全国范围内招募20名受试者，其中包括来自该中心的3-5名受试者，他们目前正在接受血浆衍生(人)α-蛋白水解酶抑制剂(Prolastin？)的强化治疗。 研究对象将被随机分配(50：50的比例)，接受第一个为期8周的治疗序列，每周使用阿尔法-1 MP或Prolastin？每周。然后受试者将交叉使用替代治疗药物进行第二次为期8周的治疗。然后，所有受试者将接受为期8周的Alpha-1 MP单独开放标签治疗。PK、病毒和免疫原性检测将在整个研究过程中继续进行。

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. In this clinical study, a plasma-derived Alpha 1-Proteinase Inhibitor product produced by an improved manufacturing process will be investigated as augmentation therapy for adult patients with Alpha1-antitrypsin deficiency and associated destructive lung disease. This multi-centered, phase III study will enroll 20 subjects nationally with 3-5 subjects from this center who are currently on augmentation therapy with plasma-derived (human) Alpha1-Proteinase Inhibitor (Prolastin¿). Study subjects will be randomly assigned (50-50 ratio) to receive the first 8-week treatment sequence with either Alpha-1 MP weekly or Prolastin¿ weekly. Then subjects will cross over to the alternate treatment drug for the second 8-week treatment. All subjects will then receive 8 weeks of open-label treatment with Alpha-1 MP exclusively. PK, viral and immunogenicity assays will continue throughout the study.