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NCT00289211 · ClinicalTrials.gov registry record · Phase 3
C1 Esterase Inhibitor (C1INH-nf) for the Treatment of Acute Hereditary Angioedema (HAE) Attacks
A Phase 3 study of Hereditary Angioedema, sponsored by Shire.
- Completed
- Registry status
- Phase 3
- Development phase
- 83
- Enrollment target
- 20
- Study locations
NCT00289211: Completed Phase 3 study of Hereditary Angioedema, sponsored by Shire.
NCT00289211 is a Phase 3 study of Hereditary Angioedema that has completed, run by Shire. The registered enrollment target is 83 participants, above the 70-participant average among 14 other Hereditary Angioedema trials with a reported enrollment target (19% higher). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00289211, a Phase 3 study of Hereditary Angioedema, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 83 participants
- Enrollment target
- 20
- Study locations
Study Summary
The study objective was to determine the safety and efficacy of C1INH-nf for the treatment of acute HAE attacks.
Primary Outcome
Randomized subjects assessed their symptoms every 15 minutes up to 4 hours after the initial dose of blinded study drug or until substantial relief of the defining symptom was achieved. Substantial relief was defined as 3 consecutive assessments of improvement of the defining symptom. Beginning of substantial relief was considered the first of the 3 consecutive assessments.
Conditions Studied
Interventions
- DRUG Placebo (saline)
- 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 Clinical Research, Inc - Walnut Creek
Florida
- Allergy and Asthma Center - Fort Lauderdale
- Orlando Regional Healthcare - Orlando
Massachusetts
- Allergy Asthma and Immunology - Falmouth
- University of Massachusetts Medical School - Worcester
New York
- Winthrop University Hospital - Mineola
- Mount Sinai School of Medicine - New York
Alabama
- Clinical Research Consultants, Inc - Hoover
Arizona
- Allergy and Immunology Associates - Scottsdale
Georgia
- Family Allergy and Asthma Center - Atlanta
Indiana
- Welborn Clinic Allergy and Immunology - Evansville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 83 participants |
| Start Date | 2005-03-14 |
| Est. Completion | 2007-04-13 |
| Phase | Phase 3 |
What the finished NCT00289211 record still lists
NCT00289211 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 83 participants, a relatively small participant target, above the 70-participant average among 14 other Hereditary Angioedema trials with a reported enrollment target (19% higher).
The record links to 1 condition, with Hereditary Angioedema appearing as the primary indexed condition, and to 2 interventions - of which Placebo (saline) is the first listed.
NCT00289211 names 20 study sites across 15 states, led by California, Florida, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT00289211 about?
NCT00289211 is a clinical study titled "C1 Esterase Inhibitor (C1INH-nf) for the Treatment of Acute Hereditary Angioedema (HAE) Attacks". The study objective was to determine the safety and efficacy of C1INH-nf for the treatment of acute HAE attacks.
What is the current status of trial NCT00289211?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 83 participants. The study started on 2005-03-14. Estimated completion is 2007-04-13.
What conditions does trial NCT00289211 study?
This clinical trial studies the following conditions: Hereditary Angioedema.
What interventions are being tested in trial NCT00289211?
The interventions under investigation include: Placebo (saline) (DRUG), C1 esterase inhibitor [human] (C1INH-nf) (BIOLOGICAL).
Who is sponsoring clinical trial NCT00289211?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00289211 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Florida, Georgia. 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 NCT00289211's enrollment target sits among peer trials
83 7th of 14 higher than 8 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
-
STOP-HAE: A Phase 3 Study of ADX-324 in HAE
RECRUITING · Phase 3
-
An Open-label Extension Trial to Evaluate the Long-term Safety of KVD900 (Sebetralstat) for On-Demand Treatment of Angioedema Attacks in Adolescent and Adult Patients With Hereditary Angioedema (HAE)
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A Study to Assess the Long-Term Safety and Efficacy of Donidalorsen in the Prophylactic Treatment of Hereditary Angioedema (HAE)
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PK Subtrial in Adolescent Patients With HAE Type I or II Participating in the KVD900-302 Trial
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Open-Label C1 Esterase Inhibitor (C1INH-nf) for the Prevention of Acute Hereditary Angioedema (HAE) Attacks
COMPLETED · Phase 3
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