A Study to Evaluate the Safety, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Subcutaneous Cinryze Administration
Information source: ViroPharma
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hereditary Angioedema
Intervention: Cinryze (Biological)
Phase: Phase 2
Status: Recruiting
Sponsored by: ViroPharma Overall contact:
Charles M. Preston, Phone: 610-321-6215, Email: charles.preston@viropharma.com
Summary
The objectives of the study are to:
1. Evaluate the safety and tolerability of Cinryze administered by subcutaneous injection
in patients with Hereditary Angioedema (HAE)
2. Characterize the PK and PD of Cinryze administered by subcutaneous injection
3. Assess the immunogenicity of Cinryze following subcutaneous administration
Clinical Details
Official title: An Open-Label, Multiple-Dose Study to Evaluate the Safety, PK, and PD of Subcutaneous Versus Intravenous (IV) Administration of Cinryze in Adolescents and Adults With HAE
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label
Primary outcome: C1INH and C4 Levels
Secondary outcome: Anti C1INH Antibodies
Eligibility
Minimum age: 12 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
To be eligible for this protocol, a subject must:
1. Have a confirmed diagnosis of HAE.
2. During the 3 consecutive months prior to screening, have a history of less than 1 HAE
attack per month (average) treated with C1 inhibitor (C1 INH) therapy or any other
blood products, ecallantide (Kalbitor), icatibant (Firazyr), anti-fibrinolytics
(e. g., tranexamic acid), IV fluids, or narcotic analgesics.
3. Agree to strictly adhere to the protocol-defined schedule of assessments and
procedures.
Exclusion Criteria:
To be eligible for this protocol, a subject must not:
1. 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.
2. Have received any ecallantide (Kalbitor), icatibant (Firazyr), or anti-fibrinolytics
(e. g., tranexamic acid) within 14 days prior to first dose.
3. 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.
4. 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.
5. Have a history of abnormal blood clotting or other coagulopathy.
6. Have a history of allergic reaction to Cinryze or other blood products.
7. Be pregnant or breastfeeding.
8. Have received an immunization within 30 days prior to the first dose.
9. Have participated in any other investigational drug study within 30 days prior to the
first dose.
Locations and Contacts
Charles M. Preston, Phone: 610-321-6215, Email: charles.preston@viropharma.com
Allergy, Asthma and Immunology Associates, Scottsdale, Arizona 85251, United States; Recruiting
Charles Preston, Phone: 610-321-6215, Email: charles.preston@viropharma.com
Family Allergy and Asthma Center, Atlanta, Georgia 30342, United States; Recruiting
Charles Preston, Phone: 610-321-6215, Email: charles.preston@viropharma.com
Institute for Asthma and Allergy, Chevy Chase, Maryland 20815, United States; Recruiting
Charles Preston, Phone: 610-321-6215, Email: charles.preston@viropharma.com
Allergy, Asthma and Dermatology Research Center, Lake Oswego, Oregon 97035, United States; Recruiting
Charles Preston, Phone: 610-321-6215, Email: charles.preston@viropharma.com
AARA Research Center, Dallas, Texas 75231, United States; Recruiting
Charles Preston, Phone: 610-321-6215, Email: charles.preston@viropharma.com
Marycliff Allergy Specialist, Spokane, Washington 99204, United States; Recruiting
Charles Preston, Phone: 610-321-6215, Email: charles.preston@viropharma.com
Additional Information
Starting date: May 2010
Last updated: July 26, 2010
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