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NCT00462709 · ClinicalTrials.gov registry record · Phase 3
Open-Label C1 Esterase Inhibitor (C1INH-nf) for the Prevention of Acute Hereditary Angioedema (HAE) Attacks
A Phase 3 study of Hereditary Angioedema, sponsored by Shire.
- Completed
- Registry status
- Phase 3
- Development phase
- 146
- Enrollment target
- 20
- Study locations
NCT00462709: Completed Phase 3 study of Hereditary Angioedema, sponsored by Shire.
NCT00462709 is a Phase 3 study of Hereditary Angioedema that has completed, run by Shire. The registered enrollment target is 146 participants, above the 65-participant average among 14 other Hereditary Angioedema trials with a reported enrollment target (125% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00462709, a Phase 3 study of Hereditary Angioedema, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 146 participants
- Enrollment target
- 20
- Study locations
Study Summary
The study objective was to evaluate the safety and efficacy of prophylactic use of C1INH-nf for the prevention of acute HAE attacks.
Primary Outcome
A hereditary angioedema (HAE) attack was defined as a discrete episode during which the subject progressed from no angioedema to symptoms of angioedema.
Conditions Studied
Interventions
- BIOLOGICAL C1 esterase inhibitor [human] (C1INH-nf)
Study Locations (20)
California
- UCLA-David Geffen School of Medicine - Los Angeles
- University of California, San Diego - San Diego
- Allergy and Asthma Associates of Santa Clara - San Jose
- Allergy and Asthma Clinical Research, Inc - Walnut Creek
Florida
- Allergy and Asthma Center - Fort Lauderdale
- Allergy and Asthma Center of East Orlando - Orlando
- Cleveland Clinic - Weston
Georgia
- Family Allergy and Asthma Center - Atlanta
- Atlanta Allergy and Asthma Clinic - Suwanee
Kansas
- Private Practice - Liberal
- Olathe Medical Center - Olathe
Kentucky
- Graves-Gilbert Clinic - Bowling Green
- Family Asthma and Allergy Research Center - Louisville
Maryland
- Asthma Allergy and Sinus Center - Waldorf
- Institute for Asthma and Allergy - Wheaton
Alabama
- Clinical Research Consultants, Inc - Hoover
Arizona
- Allergy and Immunology Associates - Scottsdale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 146 participants |
| Start Date | 2006-06-27 |
| Est. Completion | 2009-03-31 |
| Phase | Phase 3 |
What the finished NCT00462709 record still lists
NCT00462709 is an interventional study that assigns participants to a tested intervention. The registered 146 participants enrollment target is mid-sized for trials with a published cap, above the 65-participant average among 14 other Hereditary Angioedema trials with a reported enrollment target (125% higher).
The record links to 1 condition, with Hereditary Angioedema appearing as the primary indexed condition, and to 1 intervention - of which C1 esterase inhibitor [human] (C1INH-nf) is the first listed.
NCT00462709 names 20 study sites across 11 states, led by California, Florida, Georgia.
Frequently Asked Questions
What is clinical trial NCT00462709 about?
NCT00462709 is a clinical study titled "Open-Label C1 Esterase Inhibitor (C1INH-nf) for the Prevention of Acute Hereditary Angioedema (HAE) Attacks". The study objective was to evaluate the safety and efficacy of prophylactic use of C1INH-nf for the prevention of acute HAE attacks.
What is the current status of trial NCT00462709?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 146 participants. The study started on 2006-06-27. Estimated completion is 2009-03-31.
What conditions does trial NCT00462709 study?
This clinical trial studies the following conditions: Hereditary Angioedema.
What interventions are being tested in trial NCT00462709?
The interventions under investigation include: C1 esterase inhibitor [human] (C1INH-nf) (BIOLOGICAL).
Who is sponsoring clinical trial NCT00462709?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00462709 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hereditary Angioedema
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00462709's enrollment target sits among peer trials
146 2nd of 14 the highest of 14 other Hereditary Angioedema trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hereditary Angioedema trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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COMPLETED · Phase 3
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