drugset / Trial / NCT01253382

Study to Evaluate Ecallantide in Paediatric Patients With Acute Attacks of Hereditary Angioedema

NCT01253382 ↗

Phase 2/3 Withdrawn Shire
RandomizedSingle-groupQuadruple-blindTreatment

Summary

The primary objective of this study is: * assess the safety and tolerability of ecallantide in paediatric patients for acute attacks of HAE The secondary objectives are: * evaluate the pharmacokinetic profile of ecallantide in paediatric patients treated for acute attacks of HAE * assess the efficacy of ecallantide in paediatric patients treated for moderate to severe acute attacks of HAE

Timeline

Start
2012-06-01
Primary completion
2015-04-01
Completion
—

Drugs

EvaluationDrugModalityDoseRoute
Comparator ecallantide Protein / enzyme biologic 10 mg Subcutaneous
Comparator ecallantide Protein / enzyme biologic 30 mg Subcutaneous

Indications