At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 32 enrolled
Drug / intervention
Recombinant human C1 inhibitor +1 morebiological
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 2 Multicenter, Randomized, Double-Blind, Placebo-Controlled, 3-Period Crossover Study to Evaluate the Efficacy and Safety of Recombinant Human C1 Inhibitor in the Prophylaxis of Angioedema Attacks in Patients With Hereditary Angioedema (HAE)
In Brief
A Phase 2 clinical trial evaluating Recombinant human C1 inhibitor and Placebo for Hereditary Angioedema. Completed, enrolled 32 participants across 10 sites in 7 countries.
Detailed Summary
Primary Objective: To evaluate the efficacy of recombinant human C1 inhibitor (rhC1INH) in the prophylaxis of angioedema attacks in patients with HAE Secondary Objective: To evaluate the safety and immunogenicity of recombinant human C1 inhibitor (rhC1INH) in the prophylaxis of angioedema attacks in patients with HAE
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHereditary Angioedema
CountriesCanada, Czechia, Italy, North Macedonia, Romania, Serbia, United States
Collaborators--
Timeline
Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedSep 2014
Enrollment StartDec 2014
Primary CompletionMay 2016
Study CompletionSep 2016
TodayJul 2026
First PostedSep 25, 2014
Enrollment StartDec 1, 2014
Primary CompletionMay 1, 2016
Study CompletionSep 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 11.8 years ago
Interventions
Recombinant human C1 inhibitorbiological
Placeboother