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NCT01912456 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Clinical Efficacy and Safety of Subcutaneously Administered C1-esterase Inhibitor in the Prevention of Hereditary Angioedema
A Phase 3 study of Hereditary Angioedema Types I and II, sponsored by CSL Behring.
- Completed
- Registry status
- Phase 3
- Development phase
- 90
- Enrollment target
- 20
- Study locations
NCT01912456 is a Phase 3 study of Hereditary Angioedema Types I and II that has completed, run by CSL Behring. The registered enrollment target is 90 participants. The trial reports 20 study locations across 14 states.
The verdict
NCT01912456, a Phase 3 study of Hereditary Angioedema Types I and II, has completed, sponsored by CSL Behring.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 90 participants
- Enrollment target
- 20
- Study locations
Study Summary
The aim of this study is to assess the efficacy of C1-esterase inhibitor in preventing hereditary angioedema attacks when it is administered under the skin of subjects with hereditary angioedema. The safety of C1-esterase inhibitor will also be assessed. Each subject will enter a run-in period of up to 8-weeks. Subjects who complete the run-in period and who are eligible will then enter the treatment phase which comprises two sequential treatment periods. In the treatment phase, subjects will be randomized to one of four arms consisting of treatment with low- or higher-volume C1-esterase inhibitor in one treatment period and treatment with low- or higher-volume placebo in the other treatment period. The study will measure the number of hereditary angioedema attacks that subjects experience while receiving each treatment.
Conditions Studied
Interventions
- BIOLOGICAL Low-volume C1-esterase inhibitor
- BIOLOGICAL Higher-volume C1-esterase inhibitor
- BIOLOGICAL Low-volume placebo
- BIOLOGICAL Higher-volume placebo
Study Locations (20)
California
- Study Site - Bell Gardens
- Study Site - La Jolla
- Study Site - Orange
- Study Site - Walnut Creek
Ohio
- Study Site - Cincinnati
- Study Site - Columbus
- Study Site - Toledo
Virginia
- Study Site - Richmond
- Study Site - Virginia Beach
Alabama
- Study Site - Birmingham
Arizona
- Study Site - Scottsdale
Colorado
- Study Site - Colorado Springs
Maryland
- Study Site - Chevy Chase
Massachusetts
- Study Site - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2014-01 |
| Est. Completion | 2015-10 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01912456
The ClinicalTrials.gov registry entry for NCT01912456 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 90 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 1 condition, with Hereditary Angioedema Types I and II appearing as the primary indexed condition, and to 4 interventions - of which Low-volume C1-esterase inhibitor is the first listed.
NCT01912456 reports 20 study locations spanning 14 distinct geographic areas - top geographies include California, Ohio, Virginia.
Frequently Asked Questions
What is clinical trial NCT01912456 about?
NCT01912456 is a clinical study titled "A Study to Evaluate the Clinical Efficacy and Safety of Subcutaneously Administered C1-esterase Inhibitor in the Prevention of Hereditary Angioedema". The aim of this study is to assess the efficacy of C1-esterase inhibitor in preventing hereditary angioedema attacks when it is administered under the skin of subjects with hereditary angioedema. The safety of C1-esterase inhibitor will also be assessed. Each subject will enter a run-in period of up...
What is the current status of trial NCT01912456?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 90 participants. The study started on 2014-01. Estimated completion is 2015-10.
What conditions does trial NCT01912456 study?
This clinical trial studies the following conditions: Hereditary Angioedema Types I and II.
What interventions are being tested in trial NCT01912456?
The interventions under investigation include: Low-volume C1-esterase inhibitor (BIOLOGICAL), Higher-volume C1-esterase inhibitor (BIOLOGICAL), Low-volume placebo (BIOLOGICAL), Higher-volume placebo (BIOLOGICAL).
Who is sponsoring clinical trial NCT01912456?
This trial is sponsored by CSL Behring, which has 71 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01912456 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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