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

Completed · Phase 3

Conditions studied: Hereditary Angioedema (HAE)

In brief

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.

Key facts

Study ID

NCT02052141

Run by

Shire

People needed

12

Starts

2014-03-20

Expected to finish

2017-05-04

Last updated by the study team

2021-06-03

Who can join

Age: 6 and older, up to 11. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of Type I or Type II HAE.
• History of angioedema attacks.

You may not qualify if…

• History of bleeding or clotting abnormality.
• Diagnosis of acquired angioedema or known to have C1 INH antibodies.
• History of allergic reaction to C1 esterase inhibitor or other blood products.
• Receipt of any experimental agents other than those required for prevention or treatment of angioedema attacks within 30 days prior to screening.

Where it is running

• Asthma and Allergy Associates, P.C — Colorado Springs, Colorado, United States
• Nevada Access to Research and Education Society — Las Vegas, Nevada, United States
• Oregon Allergy Associates — Eugene, Oregon, United States
• Klinikum der J.W. Goethe Universitat — Frankfurt, Germany
• HZRM Hamophilie Zentrum Rhein Main GmbH — Mörfelden-Walldorf, Germany
• Tel Aviv Sourasky Medical Center — Tel Aviv, Israel
• Instituto Nacional de Pediatria — Mexico City, Mexico
• Clinical County Hospital Mures — Târgu Mureş, Romania

Full record on ClinicalTrials.gov

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