Back to resultsA Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Subcutaneous CINRYZE Administration
Primary Purpose
Hereditary Angioedema
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CINRYZE
Sponsored by
About this trial
This is an interventional other trial for Hereditary Angioedema focused on measuring HAE, C1 inhibitor (C1INH), Subcutaneous
Eligibility Criteria
Inclusion Criteria:
To be eligible for this protocol, a subject must:
- Have a confirmed diagnosis of HAE.
- 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.
- 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:
- Have received C1INH therapy or any blood products for treatment or prevention of an HAE attack within 14 days prior to the first dose.
- Have received any ecallantide (Kalbitor), icatibant (Firazyr), or antifibrinolytics (e.g., tranexamic acid) within 14 days prior to the first dose.
- 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.
- 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.
- Have a history of abnormal blood clotting or other coagulopathy.
- Have a history of allergic reaction to CINRYZE or other blood products.
- Be pregnant or breastfeeding.
- Have received an immunization within 30 days prior to the first dose.
- Have participated in any other investigational drug study within 30 days prior to the first dose.
Sites / Locations
- Allergy, Asthma and Immunology Associates
- Allergy and Asthma Clinical Research, Inc.
- Family Allergy and Asthma Center
- Institute for Asthma and Allergy
- Allergy, Asthma and Dermatology Research Center
- AARA Research Center
- Marycliff Allergy Specialists
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
IV CINRYZE First, Then SC CINRYZE Dose 1
IV CINRYZE First, Then SC CINRYZE Dose 2
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Mean Change C1 Inhibitor (C1INH)
Mean Change in Baseline in Observed Plasma Concentration of C1 Inhibitor (C1INH) Antigen. Baseline-corrected concentrations were derived by subtracting the observed pre-dose concentrations on Day 1 of each treatment period from each observed concentration.
Mean Change C4 Compliment
Mean Change in Baseline in Observed Plasma Concentration of C4 Compliment. Baseline-corrected concentrations were derived by subtracting the observed pre-dose concentrations on Day 1 of each treatment period from each observed concentration.
Number of Participants With C1 Inhibitor (INH) Antibodies
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01095497
Brief Title
A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Subcutaneous CINRYZE Administration
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 Hereditary Angioedema (HAE)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
June 7, 2010 (Actual)
Primary Completion Date
December 16, 2010 (Actual)
Study Completion Date
December 16, 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shire
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hereditary Angioedema
Keywords
HAE, C1 inhibitor (C1INH), Subcutaneous
7. Study Design
Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IV CINRYZE First, Then SC CINRYZE Dose 1
Arm Type
Experimental
Arm Title
IV CINRYZE First, Then SC CINRYZE Dose 2
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
CINRYZE
Intervention Description
C1 esterase inhibitor (human)
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Mean Change C1 Inhibitor (C1INH)
Description
Mean Change in Baseline in Observed Plasma Concentration of C1 Inhibitor (C1INH) Antigen. Baseline-corrected concentrations were derived by subtracting the observed pre-dose concentrations on Day 1 of each treatment period from each observed concentration.
Time Frame
18 days in each treatment period
Title
Mean Change C4 Compliment
Description
Mean Change in Baseline in Observed Plasma Concentration of C4 Compliment. Baseline-corrected concentrations were derived by subtracting the observed pre-dose concentrations on Day 1 of each treatment period from each observed concentration.
Time Frame
18 days in each treatment period
Title
Number of Participants With C1 Inhibitor (INH) Antibodies
Time Frame
18 days in each treatment period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
To be eligible for this protocol, a subject must:
Have a confirmed diagnosis of HAE.
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.
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:
Have received C1INH therapy or any blood products for treatment or prevention of an HAE attack within 14 days prior to the first dose.
Have received any ecallantide (Kalbitor), icatibant (Firazyr), or antifibrinolytics (e.g., tranexamic acid) within 14 days prior to the first dose.
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.
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.
Have a history of abnormal blood clotting or other coagulopathy.
Have a history of allergic reaction to CINRYZE or other blood products.
Be pregnant or breastfeeding.
Have received an immunization within 30 days prior to the first dose.
Have participated in any other investigational drug study within 30 days prior to the first dose.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
Allergy, Asthma and Immunology Associates
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
Facility Name
Allergy and Asthma Clinical Research, Inc.
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Family Allergy and Asthma Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Institute for Asthma and Allergy
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Allergy, Asthma and Dermatology Research Center
City
Lake Oswego
State/Province
Oregon
ZIP/Postal Code
97035
Country
United States
Facility Name
AARA Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Marycliff Allergy Specialists
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Subcutaneous CINRYZE Administration
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