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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 is a Phase 1 study that has completed, run by CSL Behring. The registered enrollment target is 18 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01576523
The ClinicalTrials.gov registry entry for NCT01576523 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is CSL Behring, which has 71 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which C1-esterase inhibitor - single intravenous dose is the first listed.
NCT01576523 reports 0 study locations.
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.
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