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A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Subcutaneous CINRYZE Administration

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01095497
Recruitment Status : Completed
First Posted : March 30, 2010
Results First Posted : March 8, 2012
Last Update Posted : May 9, 2014
Sponsor:
Information provided by (Responsible Party):
Shire

Tracking Information
First Submitted Date  ICMJE February 22, 2010
First Posted Date  ICMJE March 30, 2010
Results First Submitted Date  ICMJE December 23, 2011
Results First Posted Date  ICMJE March 8, 2012
Last Update Posted Date May 9, 2014
Study Start Date  ICMJE May 2010
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 7, 2012)
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 Measures  ICMJE
 (submitted: March 26, 2010)
C1INH and C4 Levels [ Time Frame: Through 18 days post first dose ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 7, 2012)
  • 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 Measures  ICMJE
 (submitted: March 26, 2010)
Anti C1INH Antibodies [ Time Frame: Through 18 days post first dose ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Subcutaneous CINRYZE Administration
Official Title  ICMJE 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 Hereditary Angioedema (HAE)
Brief Summary

The objectives of the study are to:

  1. Evaluate the safety and tolerability of CINRYZE administered by subcutaneous injection in subjects with hereditary angioedema
  2. Characterize the pharmacokinetics and pharmacodynamics of CINRYZE administered by subcutaneous injection
  3. Assess the immunogenicity of CINRYZE following subcutaneous administration
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Condition  ICMJE Hereditary Angioedema
Intervention  ICMJE Biological: CINRYZE
C1 esterase inhibitor (human)
Study Arms  ICMJE
  • Experimental: IV CINRYZE First, Then SC CINRYZE Dose 1
    Intervention: Biological: CINRYZE
  • Experimental: IV CINRYZE First, Then SC CINRYZE Dose 2
    Intervention: Biological: CINRYZE
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 6, 2011)
26
Original Estimated Enrollment  ICMJE
 (submitted: March 26, 2010)
24
Actual Study Completion Date  ICMJE December 2010
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 C1INH therapy or any other blood products, ecallantide (Kalbitor), icatibant (Firazyr), antifibrinolytics (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 C1INH 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 antifibrinolytics (e.g., tranexamic acid) within 14 days prior to the 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01095497
Other Study ID Numbers  ICMJE 0624-200
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Shire
Study Sponsor  ICMJE Shire
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Jennifer Schranz, MD Shire
PRS Account Shire
Verification Date April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP