At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 96 enrolled
Drug / intervention
ecallantide +1 moredrug
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.
EDEMA4: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of DX-88 (Ecallantide) for the Treatment of Acute Attacks of Hereditary Angioedema
In Brief
A Phase 3 clinical trial evaluating ecallantide and Phosphate Buffer Saline (PBS), pH 7.0 for Hereditary Angioedema (HAE). Completed, enrolled 96 participants across 45 sites in 3 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHereditary Angioedema (HAE)
CountriesCanada, Jordan, United States
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartApr 2007
First PostedApr 2007
Primary CompletionJun 2008
TodayJul 2026
First PostedApr 5, 2007
Enrollment StartApr 1, 2007
Primary CompletionJun 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 19.2 years ago
Interventions
ecallantidedrug
dose of 30 mg (10 mg/ml) given as 3 subcutaneous injections.
Phosphate Buffer Saline (PBS), pH 7.0drug
given as three 1mL subcutaneous injections.