At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 75 enrolled
Drug / intervention
C1 esterase inhibitor [human] liquid +1 moredrug
Likely dose
Not stated in 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 3, Randomized, Double-blind, Placebo-controlled, Two-period, Three-sequence, Partial Crossover Study to Evaluate the Efficacy and Safety of Subcutaneous Administration of 2000 IU of C1 Esterase Inhibitor [Human] Liquid for Injection for the Prevention of Angioedema Attacks in Adolescents and Adults With Hereditary Angioedema
In Brief
A Phase 3 clinical trial evaluating C1 esterase inhibitor [human] liquid and Placebo for Hereditary Angioedema (HAE). Completed, enrolled 75 participants across 27 sites in 7 countries.
Detailed Summary
The purpose of this study is to assess the efficacy and safety of subcutaneous administration of a liquid formulation of C1 esterase inhibitor for the prevention of angioedema attacks in adolescent and adult subjects with hereditary angioedema.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHereditary Angioedema (HAE)
CountriesCanada, Germany, Hungary, Israel, Romania, Spain, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedOct 2015
Enrollment StartNov 2015
Primary CompletionJul 2017
TodayJul 2026
First PostedOct 23, 2015
Enrollment StartNov 1, 2015
Primary CompletionJul 24, 2017
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 10.7 years ago
Interventions
C1 esterase inhibitor [human] liquiddrug
C1 Esterase Inhibitor \[Human\] Liquid administered Subcutaneously as specified on specified days
Placebodrug
Placebo