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

NCT00261833 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2015-01-19

Study results available
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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

BIOLOGICAL

Alpha1-proteinase inhibitor

60 mg/kg body weight/week intravenous

OTHER

Placebo

Lyophilized preparation: 60 mg/kg body weight/week intravenous

Sponsors & Collaborators

  • CSL Behring

    lead INDUSTRY

Principal Investigators

  • Senior Director Immonology & Pulmonology, Clinical R&D · CSL Behring

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-03-31
Primary Completion
2012-09-30
Completion
2012-09-30

Countries

  • United States
  • Australia
  • Canada
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • Germany
  • Ireland
  • Poland
  • Romania
  • Russia
  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00261833 on ClinicalTrials.gov