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COMPLETED Phase 3

A Study to Evaluate the Clinical Efficacy and Safety of Subcutaneously Administered C1-esterase Inhibitor in the Prevention of Hereditary Angioedema

NCT01912456 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 90 participants
Start Date 2014-01
Est. Completion 2015-10
Phase Phase 3

Sponsor

CSL Behring

85 total trials

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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. 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 90 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 4 interventions — of which Low-volume 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: NCT01912456 reports 20 study locations spanning 14 distinct geographic areas — top geographies include California, Ohio, Virginia. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01912456?

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 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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial