NCT01576523

A Study to Evaluate the Clinical Pharmacology and Safety of C1-esterase Inhibitor Administered by the Subcutaneous Route

An Open-label, Cross-over, Dose-ranging Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety of the Subcutaneous Administration of a Human Plasma-derived C1-esterase Inhibitor in Subjects With Hereditary Angioedema

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: CSL Behring · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study is to assess what happens to C1-esterase inhibitor that is administered under the skin of subjects with hereditary angioedema. Three different dosing regimens of C1-esterase inhibitor will be assessed. Each subject will be assigned to receive 2 of the 3 dosing regimens, each for 4 weeks. The activity and concentration of C1-esterase inhibitor in the blood will be measured during each 4-week period. The study will also examine how well C1-esterase inhibitor administered under the skin is tolerated by the subjects.

Conditions

• Hereditary Angioedema Types I and II

Interventions

Type	Name	Description
BIOLOGICAL	C1-esterase inhibitor - single intravenous dose	A single intravenous dose of C1-esterase inhibitor (Berinert) at 20 units per kg body weight will be administered to all subjects prior to receiving the first dose of subcutaneous C1-esterase inhibitor.
BIOLOGICAL	C1-esterase inhibitor - subcutaneous low dose	A low dose of C1-esterase inhibitor will be administered subcutaneously twice a week for four weeks.
BIOLOGICAL	C1-esterase inhibitor - subcutaneous medium dose	A medium dose of C1-esterase inhibitor will be administered subcutaneously twice a week for four weeks.
BIOLOGICAL	C1-esterase inhibitor - subcutaneous high dose	A high dose of C1-esterase inhibitor will administered subcutaneously twice a week for four weeks.

Timeline

• Start date: 2012-04-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2012-04-12
• Last updated: 2021-02-01
• Results posted: 2021-02-01

Locations

8 sites across 2 countries: United States, Germany