NCT00670007

Extension Study of Zemaira® i.v. Administration in Subjects With Emphysema Due to alpha1-proteinase Inhibitor Deficiency.

An Open-label, Non-controlled, Multicenter, Multinational Study to Evaluate the Efficacy and Safety of Zemaira® Administration in Chronic Augmentation and Maintenance Therapy in Subjects With Emphysema Due to alpha1-proteinase Inhibitor Deficiency Who Completed Clinical Study CE1226_4001

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: CSL Behring · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a continuation of the placebo-controlled study CE1226\_4001 (NCT00261833) to evaluate the efficacy and safety of Zemaira® intravenous (i.v). administration in subjects with emphysema due to alpha1-proteinase inhibitor deficiency. The long-term verification of a disease-modifying benefit of Zemaira® on the progression of emphysema will be assessed by volume-adjusted lung density, measured yearly by computed tomography (CT).

Conditions

• Emphysema
• Alpha 1-proteinase Inhibitor Deficiency

Interventions

Type	Name	Description
BIOLOGICAL	Alpha1- proteinase inhibitor [human]	Lyophilized preparation of 60 mg/kg body weight intravenously once per week

Timeline

• Start date: 2008-04-01
• Primary completion: 2014-09-01
• Completion: 2014-09-01
• First posted: 2008-05-01
• Last updated: 2016-08-15
• Results posted: 2016-07-12

Locations

21 sites across 11 countries: Australia, Canada, Czechia, Denmark, Estonia, Finland, Germany, Ireland, Poland, Romania, Sweden