Status:
COMPLETED
A Study to Evaluate the Safety and Pharmacology of Subcutaneous Administration of CINRYZE With Recombinant Human Hyaluronidase
Lead Sponsor:
Shire
Collaborating Sponsors:
Halozyme Therapeutics
Conditions:
Hereditary Angioedema
Eligibility:
All Genders
12+ years
Phase:
PHASE2
Brief Summary
The objectives of the study are to: 1. Evaluate the safety and tolerability of subcutaneously administered CINRYZE with recombinant human hyaluronidase (rHuPH20) in subjects with hereditary angioedem...
Eligibility Criteria
Inclusion
- To be eligible for this protocol, a subject must:
- Provide informed consent/assent, as appropriate.
- Have previously participated in CINRYZE Study 0624-200 and completed the subcutaneous therapy period in that study.
- During the 3 consecutive months prior to screening, have a history of less than 1 HAE attack per month (average) that required treatment with C1 INH therapy or other blood products.
- Agree to avoid his/her known HAE triggers during the study to the best of his/her ability.
Exclusion
- To be eligible for this protocol, a subject must not:
- Have received C1 INH therapy or any blood products for treatment or prevention of an HAE attack within 14 days prior to the first dose of study drug.
- Have received any ecallantide (Kalbitor), icatibant (Firazyr), or antifibrinolytics (e.g., tranexamic acid) within 14 days prior to the first dose of study drug.
- Have any change (start, stop, or change in dose) in androgen therapy (e.g., danazol, oxandrolone, stanozolol, testosterone) within 14 days prior to the first dose of study drug.
- If female, have started taking or changed the dose of any hormonal contraceptive regimen or hormone replacement therapy (i.e., estrogen/progestin containing products) within 3 months prior to the first dose of study drug.
- Have a history of abnormal blood clotting.
- Have a history of allergic reaction to products containing C1 INH or other blood products.
- Have a known allergy to hyaluronidase or any other ingredient in rHuPH20.
- Be pregnant or breastfeeding.
- Have received an investigational study drug within 30 days prior to the first dose of study drug.
Key Trial Info
Start Date :
September 12 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 28 2011
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01426763
Start Date
September 12 2011
End Date
November 28 2011
Last Update
July 19 2021
Active Locations (4)
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1
ViroPharma Investigational Site
Scottsdale, Arizona, United States, 85251
2
ViroPharma Investigational Site
Walnut Creek, California, United States, 94598
3
ViroPharma Investigational Site
Atlanta, Georgia, United States, 30342
4
ViroPharma Investigational Site
Dallas, Texas, United States, 75231