NCT02052141

Safety and Efficacy Study of CINRYZE for Prevention of Angioedema Attacks in Children Ages 6-11 With Hereditary Angioedema

A Phase 3, Multicenter, Randomized, Single-Blind, Dose-Ranging, Crossover Study to Evaluate the Safety and Efficacy of Intravenous Administration of CINRYZE® (C1 Esterase Inhibitor [Human]) for the Prevention of Angioedema Attacks in Children 6 to 11 Years of Age With Hereditary Angioedema

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 6 Years – 11 Years
• Healthy volunteers: Not accepted

Summary

Primary Objective - To assess the relative efficacy of two dose levels of CINRYZE (500 Units and 1000 Units) administered by intravenous (IV) injection every 3 or 4 days to prevent angioedema attacks in children 6 to 11 years of age with hereditary angioedema (HAE). Secondary Objectives - To assess the safety and tolerability, characterize the pharmacokinetics (PK) and pharmacodynamics (PD), and assess the immunogenicity of two dose levels of CINRYZE administered by IV injection in children 6 to 11 years of age with HAE.

Conditions

• Hereditary Angioedema (HAE)

Interventions

Type	Name	Description
BIOLOGICAL	CINRYZE 500	500 Units of CINRYZE administered by IV injection
BIOLOGICAL	CINRYZE 1000	1000 Units of CINRYZE administered by IV injection

Timeline

• Start date: 2014-03-20
• Primary completion: 2017-05-04
• Completion: 2017-05-04
• First posted: 2014-01-31
• Last updated: 2021-06-03
• Results posted: 2018-08-28

Locations

8 sites across 5 countries: United States, Germany, Israel, Mexico, Romania