At a glance
ClinicalIndex Comparison RecordN/ACompleted· 81 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.
A Phase 4, Long-Term Observational Safety Study to Evaluate Immunogenicity and Hypersensitivity With Exposure to KALBITOR (Ecallantide) for the Treatment of Acute Attacks of HAE
In Brief
An observational study evaluating ecallantide for Hereditary Angioedema (HAE). Completed, enrolled 81 participants across 40 sites.
Detailed Summary
The objective of this study is to evaluate the formation of antibodies, the occurence of allergic reactions, and the risk of hypercoagulability and hypocoagulability in patients treated with KALBITOR (ecallantide).
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsHereditary Angioedema (HAE)
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 2010
Enrollment StartFeb 2010
Primary CompletionSep 2013
Study CompletionJun 2014
TodayJul 2026
First PostedFeb 1, 2010
Enrollment StartFeb 1, 2010
Primary CompletionSep 1, 2013
Study CompletionJun 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 16.4 years ago
Interventions
ecallantidedrug
30 mg SC