Aralast alpha1-proteinase Inhibitor Surveillance Study
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.
Timeline
- Start
- 2006-06-09
- Primary completion
- 2008-12-01
- Completion
- 2009-05-01
Outcome
Met primary endpoint
Stopped: “Study terminated early due to Aralast being phased out of the market.”
registry p = 0.044; Paired t-test NCT00313144 ↗
registry p = 0.009; Paired t-test NCT00313144 ↗
registry p = 0.005; Paired t-test NCT00313144 ↗
registry p = 0.006; Paired t-test NCT00313144 ↗
registry p = 0.046; Paired t-test NCT00313144 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Alpha 1-Antitrypsin | Protein / enzyme biologic | — | — |