At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 26 enrolled
Drug / intervention
C1 esterase inhibitor [human] (C1INH-nf) +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.
LEVP2005-1/Part B: A Double-blind, Placebo-Controlled, Clinical Study to Investigate the Efficacy and Safety of Purified C1 Esterase Inhibitor (Human) as Prophylactic Treatment to Prevent HAE Attacks
In Brief
A Phase 3 clinical trial evaluating C1 esterase inhibitor [human] (C1INH-nf) and Placebo (saline) for Hereditary Angioedema. Completed, enrolled 26 participants across 16 sites.
Detailed Summary
The study objective was to determine the safety and efficacy of C1INH-nf for the prevention of acute HAE attacks.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHereditary Angioedema
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMar 2005
Primary CompletionAug 2007
First PostedNov 2009
TodayJul 2026
First PostedNov 2, 2009
Enrollment StartMar 14, 2005
Primary CompletionAug 22, 2007
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 16.7 years ago
Interventions
C1 esterase inhibitor [human] (C1INH-nf)biological
Placebo (saline)drug