A Study to Evaluate the Safety and Effect of Escalating Doses of CINRYZE

Completed · Phase 4

Conditions studied: Hereditary Angioedema

In brief

The objectives of the study were: 1. To assess the safety and tolerability of escalating doses of CINRYZE. 2. To assess the effect of an escalating dose algorithm for CINRYZE on hereditary angioedema (HAE) attack rates. 3. To assess the immunogenicity of CINRYZE.

Key facts

Study ID

NCT00914966

Run by

Shire

People needed

20

Starts

2009-08-31

Expected to finish

2012-05-24

Last updated by the study team

2021-06-23

Who can join

Age: 6 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• To be eligible for this protocol, subjects must:
• Be ≥6 years of age and ≥25 kg body weight.
• Have a confirmed diagnosis of HAE with a documented history of swelling of the face, extremities, gastrointestinal tract, genitalia, or larynx and a history of at least one of the following:
• C1 INH gene mutation
• C4 level below the lower limit of the reference range
• C1 INH antigen level below the lower limit of the reference range
• Functional C1 INH level below the lower limit of the reference range
• Family history of HAE (i.e., grandparent, parent, sibling)
• Have a history of >1.0 HAE attack per month (average) of any severity during the 3 consecutive months prior to screening while receiving the recommended CINRYZE dosing of 1000 Units every 3 to 4 days via intravenous injection.
• If an adult, be informed of the nature of the study and provide written informed consent before any study-specific procedures are performed.
• OR
• If a child, have a parent/legal guardian who is willing and able to provide written informed consent for the child to participate in the study (with assent from the child when appropriate).

You may not qualify if…

• To be eligible for this protocol, subjects must not:
• Have, as determined by the investigator and/or the sponsor's medical monitor, any surgical or medical condition that could interfere with the administration of study drug or interpretation of study results.
• Have a history of abnormal blood clotting or other coagulopathy.
• Be taking prescription anticoagulant medication.
• Have a history of allergic reaction to CINRYZE or other blood products.
• Have participated in any other investigational drug study within the past 30 days (other than CINRYZE protocols).
• Have received any blood products (other than CINRYZE) within 60 days prior to screening.
• Have any of the following laboratory values at screening:
• Hemoglobin <8 g/dL
• White blood cell count <2 x 10\^9/L or >20 x 10\^9/L
• Platelet count <50 x 10\^9/L or >400 x 10\^9/L
• Serum aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >2.0 x the upper limit of normal
• Blood urea nitrogen and/or creatinine >2.0 x the upper limit of normal
• Be pregnant or breastfeeding.

Where it is running

• Allergy, Asthma and Immunology Associates — Scottsdale, Arizona, United States
• Family Allergy and Asthma Center — Atlanta, Georgia, United States
• Institute for Asthma and Allergy — Wheaton, Maryland, United States
• Winthrop University Hospital — Mineola, New York, United States
• University of Cincinnati Medical Center — Cincinnati, Ohio, United States
• Allergy and Asthma Research Group — Eugene, Oregon, United States
• Baker Allergy, Asthma and Dermatology Research Center — Lake Oswego, Oregon, United States
• East Tennessee Center for Clinical Research — Knoxville, Tennessee, United States
• Study site — Bryan, Texas, United States
• AARA Research Center — Dallas, Texas, United States
• Marycliff Allergy Specialist — Spokane, Washington, United States

Full record on ClinicalTrials.gov

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