NCT00261833

Zemaira in Subjects With Emphysema Due to Alpha1-Proteinase Inhibitor Deficiency

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: CSL Behring · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Alpha1-proteinase Inhibitor Deficiency
• Emphysema

Interventions

Type	Name	Description
BIOLOGICAL	Alpha1-proteinase inhibitor	60 mg/kg body weight/week intravenous
OTHER	Placebo	Lyophilized preparation: 60 mg/kg body weight/week intravenous

Timeline

• Start date: 2006-03-01
• Primary completion: 2012-09-01
• Completion: 2012-09-01
• First posted: 2005-12-05
• Last updated: 2015-01-19
• Results posted: 2015-01-19

Locations

28 sites across 13 countries: United States, Australia, Canada, Czechia, Denmark, Estonia, Finland, Germany, Ireland, Poland, Romania, Russia, Sweden