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NCT00261833 · ClinicalTrials.gov registry record · Phase 4
Zemaira in Subjects With Emphysema Due to Alpha1-Proteinase Inhibitor Deficiency
A Phase 4 study, sponsored by CSL Behring.
- Completed
- Registry status
- Phase 4
- Development phase
- 180
- Enrollment target
NCT00261833: Completed Phase 4 study, sponsored by CSL Behring.
NCT00261833 is a Phase 4 study that has completed, run by CSL Behring. The registered enrollment target is 180 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00261833, a Phase 4 study, has completed, sponsored by CSL Behring.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 180 participants
- Enrollment target
Study 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).
Primary Outcome
As measured by centralized, standardized computer tomographic (CT) lung densitometry. CT scans were acquired at 2 inspiration states: TLC (ie, full inspiration) and FRC (ie, full expiration). Results were adjusted for total lung volume and are presented as point estimates for the average rate of decline in each treatment group.
Interventions
- OTHER Placebo
- BIOLOGICAL Alpha1-proteinase inhibitor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2006-03 |
| Est. Completion | 2012-09 |
| Phase | Phase 4 |
What the finished NCT00261833 record still lists
NCT00261833 is an interventional study that assigns participants to a tested intervention. The registered 180 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (65% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00261833 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00261833 about?
NCT00261833 is a clinical study titled "Zemaira in Subjects With Emphysema Due to Alpha1-Proteinase Inhibitor Deficiency". 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 ...
What is the current status of trial NCT00261833?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 180 participants. The study started on 2006-03. Estimated completion is 2012-09.
What interventions are being tested in trial NCT00261833?
The interventions under investigation include: Placebo (OTHER), Alpha1-proteinase inhibitor (BIOLOGICAL).
Who is sponsoring clinical trial NCT00261833?
This trial is sponsored by CSL Behring, which has 71 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00261833's enrollment target sits among peer trials
180 466th of 2000 higher than 1,525 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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