Clinical Trial: A Study to Evaluate the Safety and Pharmacology of Subcutaneous Administration of CINRYZE With Recombinant Human Hyaluronidase

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 Administration of CINRYZE® (C1 Esterase Inhibitor [Human]) With Recombinant Human

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 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

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 ]

Original Primary Outcome: Safety and tolerability will be determined by the 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: Through study day 18 ]

Current Secondary Outcome:

  • C1 Inhibitor (C1 INH) and C4 Levels [ Time Frame: 18 days ]
  • Number of Subjects With C1 INH Antibodies [ Time Frame: Through 30 days after final dose ]


Original Secondary Outcome:

  • Number of subjects with antibodies to C1 esterase inhibitor [ Time Frame: Through 30 days after final dose ]
  • Average concentration of C1 esterase inhibitor at steady-state [ Time Frame: Through study day 11 ]


Information By: Shire

Dates:
Date Received: August 25, 2011
Date Started: September 2011
Date Completion:
Last Updated: March 19, 2014
Last Verified: March 2014