At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 83 enrolled
Drug / intervention
C1 esterase inhibitor [human] (C1INH-nf) +1 morebiological
Likely dose
Not stated in record
Key inclusion· 2
- ✓Documented diagnosis of hereditary angioedema (HAE)
- ✓Normal C1q level
Key exclusion· 9
- ✕Low C1q level
- ✕History of B-cell malignancy
- ✕Presence of anti-C1INH autoantibody
- ✕History of allergic reaction to C1INH or other blood products
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
LEVP2005-1/Part A: A Double-blind, Placebo-Controlled, Clinical Study to Investigate the Efficacy and Safety of Purified C1 Esterase Inhibitor (Human) for the Treatment of HAE in Acute Attacks
In Brief
A Phase 3 clinical trial evaluating C1 esterase inhibitor [human] (C1INH-nf) and Placebo (saline) for Hereditary Angioedema. Completed, enrolled 83 participants across 37 sites.
Detailed Summary
The study objective was to determine the safety and efficacy of C1INH-nf for the treatment of acute HAE attacks.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHereditary Angioedema
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMar 2005
First PostedFeb 2006
Primary CompletionApr 2007
TodayJul 2026
First PostedFeb 9, 2006
Enrollment StartMar 14, 2005
Primary CompletionApr 13, 2007
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 20.4 years ago
Interventions
C1 esterase inhibitor [human] (C1INH-nf)biological
Placebo (saline)drug