drugset / Trial / NCT01760343

A Study to Evaluate the Safety and Pharmacokinetics of Two Formulations of C1-esterase Inhibitor

NCT01760343

Phase 1 Completed 16 enrolled CSL Behring
RandomizedCrossoverQuadruple-blindTreatment

Summary

A new formulation of Berinert (CSL830) is being investigated for the management of hereditary angioedema (HAE). The main aim of the study is to assess the safety of a single 1500 IU dose of the new formulation of Berinert. This study will also look at the pharmacokinetics of CSL830 relative to Berinert currently on the market.

Timeline

Start
2013-01
Primary completion
2013-03
Completion
2013-03

Drugs

EvaluationDrugModalityDoseRoute
Subject CINRYZE Protein / enzyme biologic 1500 iu Intravenous

Indications