Loading clinical trials...

COMPLETEDPHASE2

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

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

NCT01095510•Shire

View on ClinicalTrials.gov

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.

Detailed Description

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

Eligibility

Age

2 - 11 years

Sex

ALL

Healthy Volunteers

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 (11)

Asthma & Allergy Associates, P.C.

Colorado Springs, Colorado, United States

University of South Florida Asthma, Allergy and Immunology Clinical Research Unit

Tampa, Florida, United States

Institute for Asthma and Allergy, PC

Chevy Chase, Maryland, United States

Allergy & Asthma Research Group

Eugene, Oregon, United States

Baker Allergy, Asthma and Dermatology Research Center, LLC

Lake Oswego, Oregon, United States

AARA Research Center

Dallas, Texas, United States

Allergy and Asthma Research Center, P.A.

San Antonio, Texas, United States

Marycliff Allergy Specialists

Spokane, Washington, United States

Charité Universitätsmedizin Berlin, Dept. of Dermatology and Allergy

Berlin, Germany

Klinikum rechts der Isar, Technical University Munich, ENT Clinic

Munich, Germany

Key Dates

Start Date

June 2, 2010

Primary Completion Date

April 17, 2012

Completion Date

April 17, 2012

Last Updated

June 3, 2021

Enrollment

ACTUAL participants

Conditions

Hereditary Angioedema (HAE)

Interventions

CINRYZE

BIOLOGICAL

Donidalorsen Treatment in Children With Hereditary Angioedema

NCT07298447

Hereditary Angioedema (HAE)

View study

RECRUITINGPHASE3

A Study of Navenibart in Participants With Hereditary Angioedema

NCT06842823

Hereditary Angioedema (HAE)

View study

ACTIVE_NOT_RECRUITING

A Study of Lanadelumab in Teenagers and Adults With Hereditary Angioedema (HAE)

NCT05469789

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 3, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Donidalorsen Treatment in Children With Hereditary Angioedema

A Study of Navenibart in Participants With Hereditary Angioedema

A Study of Lanadelumab in Teenagers and Adults With Hereditary Angioedema (HAE)

Phase 3 Extension Study of ADX-324 in Participants With Hereditary Angioedema (HAE)

CSL312_3003 Safety and Pharmacokinetic Study in Subjects 2 to 11 Years of Age With Hereditary Angioedema

A Study to Explore Hereditary Angioedema (HAE) Symptoms and Treatment Patterns in Korean People