A Study to Evaluate the Clinical Efficacy and Safety of Subcutaneously Administered C1-esterase Inhibitor in the Prevention of Hereditary Angioedema
Public ClinicalTrials.gov record NCT01912456. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Double-blind, Randomized, Placebo-controlled, Cross-over Study to Evaluate the Clinical Efficacy and Safety of Subcutaneous Administration of Human Plasma-derived C1-esterase Inhibitor in the Prophylactic Treatment of Hereditary Angioedema
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01912456
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 90 participants
Conditions and interventions
Conditions
Interventions
- Low-volume C1-esterase inhibitor Biological
- Higher-volume C1-esterase inhibitor Biological
- Low-volume placebo Biological
- Higher-volume placebo Biological
Biological
Eligibility (public fields only)
- Age range
- 12 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 2014 (Type not available)
- Primary completion
- Oct 2015 (Actual)
- Completion
- Oct 2015 (Actual)
- Last update posted
- Jan 29, 2021
2014 – 2015
United States locations
- U.S. sites
- 19
- U.S. states
- 13
- U.S. cities
- 19
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Study Site | Birmingham | Alabama | 35209 | — |
| Study Site | Scottsdale | Arizona | 85251 | — |
| Study Site | Bell Gardens | California | 90201 | — |
| Study Site | La Jolla | California | 92093 | — |
| Study Site | Orange | California | 92868 | — |
| Study Site | Walnut Creek | California | 94598 | — |
| Study Site | Colorado Springs | Colorado | 80907 | — |
| Study Site | Chevy Chase | Maryland | 20815 | — |
| Study Site | Boston | Massachusetts | 02114 | — |
| Study Site | Cincinnati | Ohio | 45267-0563 | — |
| Study Site | Columbus | Ohio | 43235 | — |
| Study Site | Toledo | Ohio | 43617 | — |
| Study Site | Tulsa | Oklahoma | 74136 | — |
| Study Site | Lake Oswego | Oregon | 97035 | — |
| Study Site | Hershey | Pennsylvania | 17033 | — |
| Study Site | Dallas | Texas | 75231 | — |
| Study Site | Richmond | Virginia | 23298 | — |
| Study Site | Virginia Beach | Virginia | 23452 | — |
| Study Site | Spokane | Washington | 99204 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 20 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01912456, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 29, 2021 · Synced Oct 27, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01912456 live on ClinicalTrials.gov.