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

Hereditary Angioedema (HAE) Clinical Trial

Official title:
Open-Label, Single-Dose Study to Evaluate the Response and Pharmacokinetics/Pharmacodynamics of Different Doses of CINRYZE® [C1 Inhibitor (Human)] For Treatment of Acute Angioedema Attacks in Children Less Than 12 Years of Age With Hereditary Angioedema

Clinical Trial 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.

Clinical Trial Description

Each subject received CINRYZE for treatment of a single acute angioedema attack. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01095510
Study type Interventional
Source Takeda
Contact
Status Completed
Phase Phase 2
Start date June 2, 2010
Completion date April 17, 2012
View Details
See also
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