Not Signed In -
ALAD deficiency porphyria |
5-ALA dehydratase-deficient porphyria; 5-aminolaevulinic dehydratase deficiency porphyria; ADP; ALA dehydratase porphyria; ALA-D porphyria; Amino levulinic acid dehydratase deficiency; Delta-aminolevulinate dehydratase deficiency porphyria; Plumboporphyria; Porphobilinogen synthase deficiency |
Clinical Trial: Zemaira in Subjects With Emphysema Due to API Deficiency
This study is not yet open for patient recruitment.
Verified by ZLB Behring November 2005
|
Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
| Alpha1-Proteinase Inhibitor Deficiency | Drug: Alpha1-proteinase inhibitor | Phase IV |
MedlinePlus consumer health information
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Randomized, Placebo-Controlled, Double-Blind, Multicenter Phase III/IV Study to Compare the Efficacy and Safety of 60 Mg/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
Further study details as provided by ZLB Behring:
Primary Outcomes: Lung density as measured by CT
Secondary Outcomes: Number, severity and duration of exacerbations; Lung function as measured by FEV1 and DLco
Expected Total Enrollment: 100
Secondary Outcomes: Number, severity and duration of exacerbations; Lung function as measured by FEV1 and DLco
Expected Total Enrollment: 100
Study start: January 2006
Eligibility
Ages Eligible for Study: 18 Years - 60 Years, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
- Alpha1-proteinase inhibitor deficiency
Exclusion Criteria:
- Current tobacco smoker (smoking has to be ceased at least 6 months prior to study inclusion).
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00261833
Otto-Erich Girgsdies, Dr. +49 6421 39 Ext. 4019 Otto-Erich.Girgsdies@zlbbehring.com
Germany
For more information on sites participating in this study, please contact our clinical research team in,, Marburg, 35002, Germany
Otto-Erich Girgsdies, Dr. +49 642139 Ext. 3019 Otto-Erich.Girgsdies@zlbbehring.com
More Information
Study ID Numbers: CE1226_4001
Last Updated: December 8, 2005
Record first received: December 2, 2005
ClinicalTrials.gov Identifier: NCT00261833
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2006-01-10
Last Updated: December 8, 2005
Record first received: December 2, 2005
ClinicalTrials.gov Identifier: NCT00261833
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2006-01-10
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