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A Study to Evaluate the Long-term Clinical Safety and Efficacy of Subcutaneously Administered C1-esterase Inhibitor in the Prevention of Hereditary Angioedema
NCT02316353 · View on ClinicalTrials.gov ↗
Study Summary
The aim of this study is to assess the long-term safety of C1-esterase inhibitor (C1-INH) in preventing hereditary angioedema (HAE) attacks when it is administered under the skin of subjects with HAE. The safety of participating subjects will be assessed for up to 54 weeks. The long-term efficacy of C1-INH will also be assessed. Each eligible subject will enter the treatment phase, wherein subjects will be randomized to treatment with either low- or medium-volume C1-INH. Subjects who have an insufficient treatment response during the study will be given an opportunity to undergo a dose increase. The study aims to enroll eligible subjects who completed study CSL830\_3001 (NCT01912456). Subjects who did not participate in study CSL830\_3001 may also participate, if eligible and if space permits. Subjects from the United States (US) who complete Treatment Period 2 will be allowed to participate in an Extension Period. During the Extension Period participating US subjects will continue to receive treatment with open-label CSL830 for up to an additional 88 weeks.
Conditions Studied
Interventions
- BIOLOGICAL C1-esterase inhibitor
Study Locations (20)
California
- Study Site — La Jolla
- Study Site — Orange
- Study Site — Walnut Creek
Ontario
- Study Site — Hamilton
- Study Site — Ottawa
- Study Site — Toronto
Other
- Study Site — Québec
- Study Site — Pilsen
- Study Site — Berlin
Alabama
- Study Site — Birmingham
Arizona
- Study Site — Scottsdale
Maryland
- Study Site — Chevy Chase
Ohio
- Study Site — Cincinnati
Oklahoma
- Study Site — Tulsa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 126 participants |
| Start Date | 2014-12-31 |
| Est. Completion | 2017-09-21 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02316353
The ClinicalTrials.gov registry entry for NCT02316353 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 126 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is CSL Behring, which has 85 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Hereditary Angioedema Types I and II appearing as the primary indexed condition, and to 1 intervention — of which C1-esterase inhibitor is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02316353 reports 20 study locations spanning 14 distinct geographic areas — top geographies include California, Ontario, Other. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT02316353 about?
NCT02316353 is a clinical study titled "A Study to Evaluate the Long-term Clinical Safety and Efficacy of Subcutaneously Administered C1-esterase Inhibitor in the Prevention of Hereditary Angioedema". The aim of this study is to assess the long-term safety of C1-esterase inhibitor (C1-INH) in preventing hereditary angioedema (HAE) attacks when it is administered under the skin of subjects with HAE. The safety of participating subjects will be assessed for up to 54 weeks. The long-term efficacy of...
What is the current status of trial NCT02316353?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 126 participants. The study started on 2014-12-31. Estimated completion is 2017-09-21.
What conditions does trial NCT02316353 study?
This clinical trial studies the following conditions: Hereditary Angioedema Types I and II. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02316353?
The interventions under investigation include: C1-esterase inhibitor (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02316353?
This trial is sponsored by CSL Behring, which has 85 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02316353 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Maryland, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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