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Completed

NCT Number: NCT01095510

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

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.

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Key information

Conditions

Hereditary Angioedema (HAE) Angioedema Angioedemas, Hereditary Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hereditary Complement Deficiency Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Immunologic Deficiency Syndromes Primary Immunodeficiency Diseases Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Urticaria Vascular Diseases

Age range

2 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

To be eligible for this protocol, subjects must:

  • Be at least 10 kg of body weight.
  • Have a confirmed diagnosis of HAE.
  • 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:

  • Have any active infectious illness.
  • Have had a prior HAE attack and/or received any C1 INH product within 7 days prior to dosing with study drug.
  • 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.
  • Have a history of allergic reaction to C1 INH products, including CINRYZE (or any of the components of CINRYZE), or other blood products.
  • 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.

Treatment and study plan

CINRYZE

Biological

Other names: C1 inhibitor [human]

Primary outcomes

  1. Presence of Unequivocal Beginning of Relief of the Defining Attack Symptom

    Time frame: Within 4 hours following treatment

Secondary outcomes

  1. Time to Unequivocal Beginning of Relief of the Defining Attack Symptom

    Time frame: Within 4 hours following treatment

  2. Time to Complete Resolution of the Attack

    Time frame: Within 1 week following treatment

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

    Time frame: Pre-dose, 2, 4, 8 hours post dose on Day 1; Day 2, 3, 5, 8

    Data was not reported due to change in planned analysis.

Sponsors and collaborators

Lead sponsor

Shire

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Mar 30, 2010
Registry last updated
Jun 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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