At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Multi-center, Randomized Trial With I.V. Prolastin® to Evaluate Frequency of Exacerbations and Progression of Emphysema by Means of Multi-slice CT Scans in Patients With Congenital Alpha-1-antitrypsin Deficiency.
In Brief
A Phase 2 clinical trial evaluating Alpha1-Proteinase Inhibitor (Human) and Albumin (Human) 20%, United States Pharmacopeia (USP) for Alpha 1-Antitrypsin Deficiency. Completed, enrolled 77 participants across 3 sites in 3 countries.
Detailed Summary
The goal of this trial was to explore the utility of evaluating emphysema progression through CT scans measuring lung density during a 2 year period of weekly infusions of either placebo or human alpha-1-antitrypsin (AAT; Prolastin®). Exacerbation data recorded in patient diaries were also collected. All efficacy data were analyzed for potential use in evaluating Prolastin efficacy in this and other clinical trials.
Study Details
Timeline
Interventions
Weekly infusion of 60 mg/kg body weight for 2 years
Weekly infusion for 2 years. Albumin (Human) 20% will be diluted with 5% glucose to a final concentration of 2.0%.