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

Information source: Shire
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hereditary Angioedema

Intervention: CINRYZE (Biological)

Phase: Phase 2

Status: Completed

Sponsored by: Shire

Official(s) and/or principal investigator(s):
Jennifer Schranz, MD, Study Director, Affiliation: Shire

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 Details

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Presence of Unequivocal Beginning of Relief of the Defining Attack Symptom

Secondary outcome:

Time to Unequivocal Beginning of Relief of the Defining Attack Symptom

Time to Complete Resolution of the Attack

Change in C1 Inhibitor (C1 INH) Antigen and Functional C1 INH Concentrations

Detailed description: Each subject received CINRYZE for treatment of a single acute angioedema attack.

Eligibility

Minimum age: 2 Years. Maximum age: 11 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: To be eligible for this protocol, subjects must: 1. Be at least 10 kg of body weight. 2. Have a confirmed diagnosis of HAE. 3. Have an acute HAE attack and be able to initiate treatment within 8 hours after onset of symptoms. Exclusion Criteria: To be eligible for this protocol, subjects must not: 1. Have any active infectious illness. 2. Have had a prior HAE attack and/or received any C1 INH product within 7 days prior to dosing with study drug. 3. Have received therapy with antifibrinolytics (e. g., tranexamic acid), androgens (e. g., danazol, oxandrolone, stanozolol, or testosterone), ecallantide (Kalbitor®), or icatibant (Firazyr®) within 7 days prior to dosing with study drug. 4. Have a history of allergic reaction to C1 INH products, including CINRYZE (or any of the components of CINRYZE), or other blood products. 5. Have participated in any other investigational drug evaluation within 30 days prior to dosing with study drug, or have previously received treatment with CINRYZE in this study at any time.

Locations and Contacts

Charité Universitätsmedizin Berlin, Dept. of Dermatology and Allergy, Berlin, Germany

Klinikum rechts der Isar, Technical University Munich, ENT Clinic, Munich, Germany

Semmelweis University, Allergy and Angioedema Outpatients Clinic, Kútvölgyi Clinical Center, Budapest, Hungary

Asthma & Allergy Associates, P.C., Colorado Springs, Colorado 80907, United States

University of South Florida Asthma, Allergy and Immunology Clinical Research Unit, Tampa, Florida 33613, United States

Institute for Asthma and Allergy, PC, Chevy Chase, Maryland 20815, United States

Allergy & Asthma Research Group, Eugene, Oregon 97401, United States

Baker Allergy, Asthma and Dermatology Research Center, LLC, Lake Oswego, Oregon 97035, United States

AARA Research Center, Dallas, Texas 75231, United States

Allergy and Asthma Research Center, P.A., San Antonio, Texas 78229, United States

Marycliff Allergy Specialists, Spokane, Washington 99204, United States

Additional Information

Starting date: March 2010
Last updated: July 14, 2015

Page last updated: August 23, 2015

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