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NCT00262080 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety Study of DX-88 to Treat Acute Attacks of Hereditary Angioedema (HAE)
A Phase 3 study, sponsored by Shire.
- Completed
- Registry status
- Phase 3
- Development phase
- 91
- Enrollment target
NCT00262080: Completed Phase 3 study, sponsored by Shire.
NCT00262080 is a Phase 3 study that has completed, run by Shire. The registered enrollment target is 91 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
NCT00262080, a Phase 3 study, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 91 participants
- Enrollment target
Study Summary
The purpose of this study is to determine if a subcutaneous dose of DX-88 (ecallantide; an investigational product) is safe and relieves symptoms of HAE in patients suffering from moderate to severe acute attacks of HAE.
Primary Outcome
Treatment Outcome Score (TOS) is a validated, comprehensive measure of symptom response to treatment. At 4 hours , patient assessment of response characterized by their change from baseline in symptom severity and collected by anatomic site of attack involvement, was recorded on a categorical scale (significant improvement \[100\] to significant worsening \[-100\]). The response at each anatomic site was weighted by baseline severity and then the weighted scores across all involved sites were av
Interventions
- DRUG ecallantide
- DRUG Phosphate Buffer Saline (PBS),
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 91 participants |
| Start Date | 2005-12-31 |
| Est. Completion | 2007-02-28 |
| Phase | Phase 3 |
What the finished NCT00262080 record still lists
NCT00262080 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 91 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.
NCT00262080 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00262080 about?
NCT00262080 is a clinical study titled "Efficacy and Safety Study of DX-88 to Treat Acute Attacks of Hereditary Angioedema (HAE)". The purpose of this study is to determine if a subcutaneous dose of DX-88 (ecallantide; an investigational product) is safe and relieves symptoms of HAE in patients suffering from moderate to severe acute attacks of HAE.
What is the current status of trial NCT00262080?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 91 participants. The study started on 2005-12-31. Estimated completion is 2007-02-28.
What interventions are being tested in trial NCT00262080?
The interventions under investigation include: ecallantide (DRUG), Phosphate Buffer Saline (PBS), (DRUG).
Who is sponsoring clinical trial NCT00262080?
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 NCT00262080's enrollment target sits among peer trials
91 1724th of 2000 higher than 277 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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