Aralast alpha1-proteinase Inhibitor Surveillance Study
Status:
Terminated
Trial end date:
2009-05-01
Target enrollment:
Participant gender:
Summary
The primary objectives of this Phase 4, open label, prospective U.S. surveillance study are
to evaluate the health outcomes of Alpha 1-Antitrypsin (AAT)-deficient subjects who are
initiating treatment with ARALAST on patient-related outcomes (PRO), i.e., health-related
quality of life (HRQoL), healthcare resource utilization (HCRU), and various laboratory
analyses to evaluate the safety of long-term administration of ARALAST.
Up to 120 subjects will be enrolled and assessed for HRQoL and HCRU at baseline and every
6-months thereafter, for 2 years. A subset of subjects will be enrolled into the blood draw
portion of the study, which will also include assessments of antibodies to ARALAST, and
chemistry panel. Subjects will be treated according to the prescribing (attending)
physician's instructions based on the prescribing information given in the ARALAST package
insert.