At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Placebo-Controlled, Double-Blind, Multicenter Phase III/IV Study to Compare the Efficacy and Safety of 60mg/kg Body Weight of Zemaira® Weekly I.V. Administration With Placebo Weekly I.V. Administration in Chronic Augmentation and Maintenance Therapy in Subjects With Emphysema Due to Alpha1-Proteinase Inhibitor Deficiency
In Brief
A Phase 4 clinical trial evaluating Alpha1-proteinase inhibitor and Placebo for Alpha1-proteinase Inhibitor Deficiency and Emphysema. Completed, enrolled 180 participants across 28 sites in 13 countries.
Detailed Summary
This is a randomized, placebo-controlled, double-blind, multicenter phase III/IV study to compare the efficacy and safety of Zemaira® with placebo in subjects with emphysema due to alpha1-proteinase inhibitor deficiency. The effect of Zemaira® on the progression of emphysema will be assessed by the decline of lung density, measured by computed tomography (CT).
Study Details
Timeline
Interventions
60 mg/kg body weight/week intravenous
Lyophilized preparation: 60 mg/kg body weight/week intravenous