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

Hereditary Angioedema Types I and II Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Angioedema
Hereditary Angioedema Types I and II

Clinical Trial Details

NCT number	NCT01576523
Study type	Interventional
Source	CSL Behring
Contact
Status	Completed
Phase	Phase 1/Phase 2
Start date	April 2012
Completion date	December 2012

View Details

See also
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