drugset / Trial / NCT00851409

A Study of the Safety and Immunogenicity of Repeated rhC1INH Administration

NCT00851409 ↗

Phase 2 Completed 25 enrolled Pharming Technologies B.V.
NaSingle-groupOpen-labelTreatment

Summary

Hereditary angioedema ("HAE") is a disease characterized by recurrent tissue swelling affecting various body locations. Recent literature shows that patients with frequent attacks may benefit from long-term prophylaxis. This study aims to evaluate the safety and prophylactic effect of weekly administrations of 50 IU/kg recombinant C1 Inhibitor ("rhC1INH").

Timeline

Start
2009-06
Primary completion
2010-03
Completion
2010-04

Drugs

EvaluationDrugModalityDoseRoute
Subject recombinant human C1 inhibitor Protein / enzyme biologic 50 iu/kg Intravenous

Indications