CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 147 enrolled
Drug / intervention
ecallantidedrug
Likely dose
ecallantide 30 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00456508
NCT00456508Phase 3Completed

Open-label Patient Continuation of DX-88 (Ecallantide) for Acute Hereditary Angioedema Attacks

Shire·interventional·Posted Apr 5, 2007·Updated Jun 8, 2021

In Brief

A Phase 3 clinical trial evaluating ecallantide for Hereditary Angioedema (HAE). Completed, enrolled 147 participants across 41 sites in 3 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, Jordan, United States
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 5, 2007
Enrollment StartApr 1, 2007
Primary CompletionJun 1, 2010
Study CompletionSep 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 19.2 years ago

Interventions

ecallantidedrug

solution for SC injection, one 30 mg dose per HAE attack