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NCT01576523 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Clinical Pharmacology and Safety of C1-esterase Inhibitor Administered by the Subcutaneous Route
A Phase 1 study, sponsored by CSL Behring.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT01576523: Completed Phase 1 study, sponsored by CSL Behring.
NCT01576523 is a Phase 1 study that has completed, run by CSL Behring. The registered enrollment target is 18 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01576523, a Phase 1 study, has completed, sponsored by CSL Behring.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
Study Summary
The aim of the study is to assess what happens to C1-esterase inhibitor that is administered under the skin of subjects with hereditary angioedema. Three different dosing regimens of C1-esterase inhibitor will be assessed. Each subject will be assigned to receive 2 of the 3 dosing regimens, each for 4 weeks. The activity and concentration of C1-esterase inhibitor in the blood will be measured during each 4-week period. The study will also examine how well C1-esterase inhibitor administered under the skin is tolerated by the subjects.
Primary Outcome
Mean trough C1-esterase inhibitor functional activity of the low, medium and high subcutaneous dose regimens, based on modeling and simulation
Interventions
- BIOLOGICAL C1-esterase inhibitor - single intravenous dose
- BIOLOGICAL C1-esterase inhibitor - subcutaneous low dose
- BIOLOGICAL C1-esterase inhibitor - subcutaneous medium dose
- BIOLOGICAL C1-esterase inhibitor - subcutaneous high dose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2012-04 |
| Est. Completion | 2012-12 |
| Phase | Phase 1 |
What the finished NCT01576523 record still lists
NCT01576523 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 4 interventions - of which C1-esterase inhibitor - single intravenous dose is the first listed.
NCT01576523 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01576523 about?
NCT01576523 is a clinical study titled "A Study to Evaluate the Clinical Pharmacology and Safety of C1-esterase Inhibitor Administered by the Subcutaneous Route". The aim of the study is to assess what happens to C1-esterase inhibitor that is administered under the skin of subjects with hereditary angioedema. Three different dosing regimens of C1-esterase inhibitor will be assessed. Each subject will be assigned to receive 2 of the 3 dosing regimens, each for...
What is the current status of trial NCT01576523?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2012-04. Estimated completion is 2012-12.
What interventions are being tested in trial NCT01576523?
The interventions under investigation include: C1-esterase inhibitor - single intravenous dose (BIOLOGICAL), C1-esterase inhibitor - subcutaneous low dose (BIOLOGICAL), C1-esterase inhibitor - subcutaneous medium dose (BIOLOGICAL), C1-esterase inhibitor - subcutaneous high dose (BIOLOGICAL).
Who is sponsoring clinical trial NCT01576523?
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 NCT01576523's enrollment target sits among peer trials
18 1720th of 2000 higher than 216 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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