Clinical Trial: A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Subcutaneous CINRYZE Administration
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: An Open-Label Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Subcutaneous (SC) Versus Intravenous (IV) Administration of CINRYZE in Adolescents and Adults With H
Brief Summary:
The objectives of the study are to:
- Evaluate the safety and tolerability of CINRYZE administered by subcutaneous injection in subjects with hereditary angioedema
- Characterize the pharmacokinetics and pharmacodynamics of CINRYZE administered by subcutaneous injection
- Assess the immunogenicity of CINRYZE following subcutaneous administration
Detailed Summary:
Sponsor: Shire
Current Primary Outcome: Incidence and Severity of Adverse Events, Number of Subjects With Local Injection Site Reactions, and Number of Subjects Who Discontinue Study Drug or Withdraw From the Study. [ Time Frame: 18 days in each treatment period ]
Original Primary Outcome: C1INH and C4 Levels [ Time Frame: Through 18 days post first dose ]
Current Secondary Outcome:
- C1 Inhibitor (C1INH) and C4 Levels [ Time Frame: 18 days in each treatment period ]
- Number of Subjects With C1INH Antibodies [ Time Frame: 18 days in each treatment period ]
Original Secondary Outcome: Anti C1INH Antibodies [ Time Frame: Through 18 days post first dose ]
Information By: Shire
Dates:
Date Received: February 22, 2010
Date Started: May 2010
Date Completion:
Last Updated: April 24, 2014
Last Verified: April 2014
