A Study to Evaluate the Safety and Pharmacology of Subcutaneous Administration of CINRYZE With Recombinant Human Hyaluronidase
Completed · Phase 2
Conditions studied: Hereditary Angioedema
In brief
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 angioedema (HAE) who previously participated in CINRYZE Study 0624-200 (NCT01095497) 2. Characterize the pharmacokinetics and pharmacodynamics of subcutaneously administered CINRYZE with rHuPH20 3. Assess the immunogenicity of CINRYZE following subcutaneous (SC) administration of CINRYZE with rHuPH20
Key facts
- Study ID
- NCT01426763
- Run by
- Shire
- People needed
- 12
- Starts
- 2011-09-12
- Expected to finish
- 2011-11-28
- Last updated by the study team
- 2021-07-19
Who can join
Age: 12 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- ViroPharma Investigational Site — Scottsdale, Arizona, United States
- ViroPharma Investigational Site — Walnut Creek, California, United States
- ViroPharma Investigational Site — Atlanta, Georgia, United States
- ViroPharma Investigational Site — Dallas, Texas, United States
Full record on ClinicalTrials.gov
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