NCT01912456

A Study to Evaluate the Clinical Efficacy and Safety of Subcutaneously Administered C1-esterase Inhibitor in the Prevention of Hereditary Angioedema

A Double-blind, Randomized, Placebo-controlled, Cross-over Study to Evaluate the Clinical Efficacy and Safety of Subcutaneous Administration of Human Plasma-derived C1-esterase Inhibitor in the Prophylactic Treatment of Hereditary Angioedema

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: CSL Behring · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to assess the efficacy of C1-esterase inhibitor in preventing hereditary angioedema attacks when it is administered under the skin of subjects with hereditary angioedema. The safety of C1-esterase inhibitor will also be assessed. Each subject will enter a run-in period of up to 8-weeks. Subjects who complete the run-in period and who are eligible will then enter the treatment phase which comprises two sequential treatment periods. In the treatment phase, subjects will be randomized to one of four arms consisting of treatment with low- or higher-volume C1-esterase inhibitor in one treatment period and treatment with low- or higher-volume placebo in the other treatment period. The study will measure the number of hereditary angioedema attacks that subjects experience while receiving each treatment.

Conditions

• Hereditary Angioedema Types I and II

Interventions

Type	Name	Description
BIOLOGICAL	Low-volume C1-esterase inhibitor
BIOLOGICAL	Higher-volume C1-esterase inhibitor
BIOLOGICAL	Low-volume placebo
BIOLOGICAL	Higher-volume placebo

Timeline

• Start date: 2014-01-01
• Primary completion: 2015-10-01
• Completion: 2015-10-01
• First posted: 2013-07-31
• Last updated: 2021-01-29
• Results posted: 2021-01-29

Locations

39 sites across 10 countries: United States, Australia, Canada, Czechia, Hungary, Israel, Italy, Romania, Spain, United Kingdom