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NCT00456508 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy Study of Repeated Doses of DX-88 (Ecallantide) to Treat Attacks of Hereditary Angioedema (HAE)
A Phase 3 study, sponsored by Shire.
- Completed
- Registry status
- Phase 3
- Development phase
- 147
- Enrollment target
NCT00456508 is a Phase 3 study that has completed, run by Shire. The registered enrollment target is 147 participants.
The verdict
NCT00456508, a Phase 3 study, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 147 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the efficacy and safety of repeated doses of ecallantide in the treatment of acute attacks of hereditary angioedema and to allow HAE patients continued access to ecallantide. In addition, patients enrolled in DX-88/20 (EDEMA4) trial will be followed up and treated for subsequent attacks in this trial.
Interventions
- DRUG ecallantide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 147 participants |
| Start Date | 2007-04-01 |
| Est. Completion | 2010-09-01 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00456508
The ClinicalTrials.gov registry entry for NCT00456508 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 147 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Shire, which has 245 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which ecallantide is the first listed.
NCT00456508 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00456508 about?
NCT00456508 is a clinical study titled "Safety and Efficacy Study of Repeated Doses of DX-88 (Ecallantide) to Treat Attacks of Hereditary Angioedema (HAE)". The purpose of this study is to evaluate the efficacy and safety of repeated doses of ecallantide in the treatment of acute attacks of hereditary angioedema and to allow HAE patients continued access to ecallantide. In addition, patients enrolled in DX-88/20 (EDEMA4) trial will be followed up and tr...
What is the current status of trial NCT00456508?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 147 participants. The study started on 2007-04-01. Estimated completion is 2010-09-01.
What interventions are being tested in trial NCT00456508?
The interventions under investigation include: ecallantide (DRUG).
Who is sponsoring clinical trial NCT00456508?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
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