At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 91 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.
A Double-blind, Placebo-controlled Study (72 Patients, Randomized 1:1) Followed by a Repeat-dosing Phase to Assess the Efficacy and Safety of DX-88 (Ecallantide; Recombinant Plasma Kallikrein Inhibitor) for the Treatment of Acute Attacks of Hereditary Angioedema
In Brief
A Phase 3 clinical trial evaluating ecallantide and Phosphate Buffer Saline (PBS), for Hereditary Angioedema (HAE). Completed, enrolled 91 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHereditary Angioedema (HAE)
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 2005
Enrollment StartDec 2005
Primary CompletionDec 2005
Study CompletionFeb 2007
TodayJul 2026
First PostedDec 6, 2005
Enrollment StartDec 31, 2005
Primary CompletionDec 31, 2005
Study CompletionFeb 28, 2007
TodayJul 2, 2026
Enrollment to primary: 0 daysPosted 20.6 years ago
Interventions
ecallantidedrug
dose of 30 mg (10 mg/ml) given as 3 subcutaneous injections.
Phosphate Buffer Saline (PBS),drug
given as three 1mL subcutaneous injections.