At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 113 enrolled
Drug / intervention
C1 esterase inhibitor [human] (C1INH-nf)biological
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.
LEVP2006-1 CHANGE 2 Trial (C1-Inhibitor in Hereditary Angioedema Nanofiltration Generation Evaluating Efficacy): Open-Label Safety/Efficacy Repeat Exposure Study of C1INH-nf (Human) in the Treatment of Acute HAE Attacks
In Brief
A Phase 3 clinical trial evaluating C1 esterase inhibitor [human] (C1INH-nf) for Hereditary Angioedema. Completed, enrolled 113 participants across 30 sites.
Detailed Summary
The study objective was to evaluate the safety and efficacy of repeat use 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
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartSep 2006
First PostedFeb 2007
Primary CompletionMar 2009
TodayJul 2026
First PostedFeb 22, 2007
Enrollment StartSep 21, 2006
Primary CompletionMar 31, 2009
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 19.4 years ago
Interventions
C1 esterase inhibitor [human] (C1INH-nf)biological