CLINICAL TRIAL: CHAMP

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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.