drugset / Trial / NCT01188564

Efficacy, Safety and Immunogenicity Study of Recombinant Human C1 Inhibitor for the Treatment of Acute HAE Attacks

NCT01188564 ↗

Phase 3 Completed 75 enrolled Pharming Technologies B.V.
RandomizedParallel-groupDouble-blindTreatment

Summary

This study is being conducted to confirm the efficacy, safety, and immunogenicity of recombinant human C1 inhibitor (rhC1INH) at a dose of 50 U/kg when used for the treatment of acute angioedema attacks in Hereditary Angioedema (HAE) patients.

Timeline

Start
2011-01
Primary completion
2012-12
Completion
2013-03

Drugs

EvaluationDrugModalityDoseRoute
Subject rhC1INH Protein / enzyme biologic 50 iu/kg Intravenous
Subject rhC1INH Protein / enzyme biologic 4200 iu Intravenous

Indications