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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 is a Phase 3 study that has completed, run by Shire. The registered enrollment target is 96 participants.

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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.

Interventions

  • DRUG ecallantide
  • DRUG Phosphate Buffer Saline (PBS), pH 7.0

Trial Details

FieldValue
Enrollment Target 96 participants
Start Date 2007-04-01
Est. Completion 2008-06-01
Phase Phase 3

Sponsor

Shire

245 total trials

What the Registry Record Tells You About NCT00457015

The ClinicalTrials.gov registry entry for NCT00457015 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 96 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 2 interventions - of which ecallantide is the first listed.

NCT00457015 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.