CHAMP

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。 在本临床研究中，将研究通过改进的生产工艺生产的血浆来源的α 1-蛋白酶抑制剂产品作为α-1-抗胰蛋白酶缺乏症和相关破坏性肺病成人患者的强化治疗。 这项多中心、III期研究将在全国范围内招募20例受试者，其中3-5例受试者来自该中心，目前正在接受血浆来源（人）α-1-蛋白酶抑制剂（Prolastin <$）的强化治疗。 研究受试者将被随机分配（50-50的比例）接受前8周治疗序列，每周一次α-1 MP或每周一次Prolastin。 然后，受试者将交叉使用替代治疗药物进行第二次8周治疗。 然后，所有受试者将接受8周的开放标签治疗，仅使用Alpha-1 MP。 PK、病毒和免疫原性试验将在整个研究期间继续进行。

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 Alpha-1-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) Alpha-1-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.