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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT01095497
First received: February 22, 2010
Last updated: March 19, 2014
Last verified: March 2014

February 22, 2010
March 19, 2014
May 2010
December 2010   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
C1INH and C4 Levels [ Time Frame: Through 18 days post first dose ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01095497 on ClinicalTrials.gov Archive Site
  • C1 Inhibitor (C1INH) and C4 Levels [ Time Frame: 18 days in each treatment period ] [ Designated as safety issue: No ]
  • Number of Subjects With C1INH Antibodies [ Time Frame: 18 days in each treatment period ] [ Designated as safety issue: Yes ]
Anti C1INH Antibodies [ Time Frame: Through 18 days post first dose ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Subcutaneous CINRYZE Administration
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)

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
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Hereditary Angioedema
Biological: CINRYZE
C1 inhibitor (human)
  • Experimental: IV CINRYZE First, Then SC CINRYZE Dose 1
    Intervention: Biological: CINRYZE
  • Experimental: IV CINRYZE First, Then SC CINRYZE Dose 2
    Intervention: Biological: CINRYZE
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
December 2010
December 2010   (final data collection date for primary outcome measure)

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.
Both
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01095497
0624-200
No
Shire
Shire
Not Provided
Not Provided
Shire
March 2014

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