Clinical Trial Results:
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
Summary
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EudraCT number |
2005-003459-12 |
Trial protocol |
IE DE FI EE SE CZ DK BG |
Global completion date |
26 Sep 2012
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Paediatric regulatory details
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Is the trial part of an agreed EMA paediatric investigation plan? |
No
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Is the trial in scope of article 45 of Regulation (EC) No 1901/2006? |
No
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Is the trial in scope of article 46 of Regulation (EC) No 1901/2006? |
No
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Results information
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Results version number |
v1(current) |
This version publication date |
06 Jan 2017
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First version publication date |
06 Jan 2017
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Other versions |
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Summary report(s) |
CSL_CE1226_4001_Result_Summary |
Note: The legislation allows summary attachments to be posted instead of the full dataset for this trial. Refer to Commission Guideline 2012/C 302/03
for further information.