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NCT00457015 · ClinicalTrials.gov registry record · Phase 3
Efficacy Study of DX-88 (Ecallantide) to Treat Acute Attacks of Hereditary Angioedema (HAE)
A Phase 3 study, sponsored by Shire.
- Completed
- Registry status
- Phase 3
- Development phase
- 96
- Enrollment target
NCT00457015: Completed Phase 3 study, sponsored by Shire.
NCT00457015 is a Phase 3 study that has completed, run by Shire. The registered enrollment target is 96 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00457015, a Phase 3 study, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 96 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the efficacy and safety of DX-88 (ecallantide) versus placebo in the treatment of moderate to severe acute attacks of hereditary angioedema.
Primary Outcome
The Mean Symptom Complex Severity (MSCS) score is a validated, comprehensive point-in-time measure of symptom severity. At baseline and 4 hours, patients rated the severity on a categorical scale (0 = normal, 1 = mild, 2 = moderate, 3 = severe) for symptoms at each affected anatomical location. Ratings were averaged to obtain the MSCS score. A decrease in MSCS score reflected an improvement in symptoms; clinically meaningful improvement was indicated by a reduction in the score of 0.30 or more.
Interventions
- DRUG ecallantide
- DRUG Phosphate Buffer Saline (PBS), pH 7.0
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 96 participants |
| Start Date | 2007-04-01 |
| Est. Completion | 2008-06-01 |
| Phase | Phase 3 |
What the finished NCT00457015 record still lists
NCT00457015 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 96 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 2 interventions - of which ecallantide is the first listed.
NCT00457015 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00457015 about?
NCT00457015 is a clinical study titled "Efficacy Study of DX-88 (Ecallantide) to Treat Acute Attacks of Hereditary Angioedema (HAE)". The purpose of this study is to evaluate the efficacy and safety of DX-88 (ecallantide) versus placebo in the treatment of moderate to severe acute attacks of hereditary angioedema.
What is the current status of trial NCT00457015?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 96 participants. The study started on 2007-04-01. Estimated completion is 2008-06-01.
What interventions are being tested in trial NCT00457015?
The interventions under investigation include: ecallantide (DRUG), Phosphate Buffer Saline (PBS), pH 7.0 (DRUG).
Who is sponsoring clinical trial NCT00457015?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00457015's enrollment target sits among peer trials
96 1718th of 2000 higher than 282 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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