drugset / Trial / NCT01095510

CINRYZE for the Treatment of Hereditary Angioedema Attacks in Children Under the Age of 12

NCT01095510

Phase 2 Completed 9 enrolled Shire
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The objectives of this study were to evaluate: (1) the dose response and (2) the pharmacokinetics (PK) and pharmacodynamics (PD) of intravenous (IV) administration of CINRYZE for the treatment of acute angioedema attacks in children above and below 25 kg and less than 12 years of age with hereditary angioedema (HAE); and (3) to determine the safety and tolerability following IV administration of CINRYZE in this study population.

Timeline

Start
2010-06-02
Primary completion
2012-04-17
Completion
2012-04-17

Drugs

EvaluationDrugModalityDoseRoute
Subject CINRYZE Protein / enzyme biologic 500 iu Intravenous
Subject CINRYZE Protein / enzyme biologic 1000 iu Intravenous
Subject CINRYZE Protein / enzyme biologic 1500 iu Intravenous

Indications