drugset / Trial / NCT01359969

Safety of Ruconest in 2-13 Year Old Hereditary Angioedema (HAE) Patients

NCT01359969 ↗

Phase 2 Completed 57 enrolled Pharming Technologies B.V.
NaSingle-groupOpen-labelTreatment

Summary

This open-label study is being conducted to confirm the safety, pharmacokinetic profile and efficacy of Ruconest at a dose of 50 U/kg when used for the treatment of acute angioedema attacks in patients, from 2 up to and including 13 years of age.

Timeline

Start
2012-01-17
Primary completion
2017-07-17
Completion
2017-07-17

Drugs

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

Indications