A Study to Evaluate the Clinical Pharmacology and Safety of C1-esterase Inhibitor Administered by the Subcutaneous Route
NCT ID: NCT01576523
Last Updated: 2021-02-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
18 participants
INTERVENTIONAL
2012-04-30
2012-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
CROSSOVER
PREVENTION
NONE
Study Groups
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Low, then medium, C1-esterase inhibitor dose
C1-esterase inhibitor - single intravenous dose
A single intravenous dose of C1-esterase inhibitor (Berinert) at 20 units per kg body weight will be administered to all subjects prior to receiving the first dose of subcutaneous C1-esterase inhibitor.
C1-esterase inhibitor - subcutaneous low dose
A low dose of C1-esterase inhibitor will be administered subcutaneously twice a week for four weeks.
C1-esterase inhibitor - subcutaneous medium dose
A medium dose of C1-esterase inhibitor will be administered subcutaneously twice a week for four weeks.
Medium, then low, C1-esterase inhibitor dose
C1-esterase inhibitor - single intravenous dose
A single intravenous dose of C1-esterase inhibitor (Berinert) at 20 units per kg body weight will be administered to all subjects prior to receiving the first dose of subcutaneous C1-esterase inhibitor.
C1-esterase inhibitor - subcutaneous low dose
A low dose of C1-esterase inhibitor will be administered subcutaneously twice a week for four weeks.
C1-esterase inhibitor - subcutaneous medium dose
A medium dose of C1-esterase inhibitor will be administered subcutaneously twice a week for four weeks.
Medium, then high, C1-esterase inhibitor dose
C1-esterase inhibitor - single intravenous dose
A single intravenous dose of C1-esterase inhibitor (Berinert) at 20 units per kg body weight will be administered to all subjects prior to receiving the first dose of subcutaneous C1-esterase inhibitor.
C1-esterase inhibitor - subcutaneous medium dose
A medium dose of C1-esterase inhibitor will be administered subcutaneously twice a week for four weeks.
C1-esterase inhibitor - subcutaneous high dose
A high dose of C1-esterase inhibitor will administered subcutaneously twice a week for four weeks.
Low, then high, C1-esterase inhibitor dose
C1-esterase inhibitor - single intravenous dose
A single intravenous dose of C1-esterase inhibitor (Berinert) at 20 units per kg body weight will be administered to all subjects prior to receiving the first dose of subcutaneous C1-esterase inhibitor.
C1-esterase inhibitor - subcutaneous low dose
A low dose of C1-esterase inhibitor will be administered subcutaneously twice a week for four weeks.
C1-esterase inhibitor - subcutaneous high dose
A high dose of C1-esterase inhibitor will administered subcutaneously twice a week for four weeks.
High, then low, C1-esterase inhibitor dose
C1-esterase inhibitor - single intravenous dose
A single intravenous dose of C1-esterase inhibitor (Berinert) at 20 units per kg body weight will be administered to all subjects prior to receiving the first dose of subcutaneous C1-esterase inhibitor.
C1-esterase inhibitor - subcutaneous low dose
A low dose of C1-esterase inhibitor will be administered subcutaneously twice a week for four weeks.
C1-esterase inhibitor - subcutaneous high dose
A high dose of C1-esterase inhibitor will administered subcutaneously twice a week for four weeks.
High, then medium, C1-esterase inhibitor dose
C1-esterase inhibitor - single intravenous dose
A single intravenous dose of C1-esterase inhibitor (Berinert) at 20 units per kg body weight will be administered to all subjects prior to receiving the first dose of subcutaneous C1-esterase inhibitor.
C1-esterase inhibitor - subcutaneous medium dose
A medium dose of C1-esterase inhibitor will be administered subcutaneously twice a week for four weeks.
C1-esterase inhibitor - subcutaneous high dose
A high dose of C1-esterase inhibitor will administered subcutaneously twice a week for four weeks.
Interventions
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C1-esterase inhibitor - single intravenous dose
A single intravenous dose of C1-esterase inhibitor (Berinert) at 20 units per kg body weight will be administered to all subjects prior to receiving the first dose of subcutaneous C1-esterase inhibitor.
C1-esterase inhibitor - subcutaneous low dose
A low dose of C1-esterase inhibitor will be administered subcutaneously twice a week for four weeks.
C1-esterase inhibitor - subcutaneous medium dose
A medium dose of C1-esterase inhibitor will be administered subcutaneously twice a week for four weeks.
C1-esterase inhibitor - subcutaneous high dose
A high dose of C1-esterase inhibitor will administered subcutaneously twice a week for four weeks.
Eligibility Criteria
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Inclusion Criteria
* Laboratory-confirmed hereditary angioedema type I or II.
* Less than two hereditary angioedema attacks per month in the last three months.
* Body weight of 50.0 kg to 110.0 kg.
Exclusion Criteria
* Received C1-esterase inhibitor, ecallantide, icatibant or any blood products for the prevention or treatment of hereditary angioedema within 7 days before the screening visit.
* Intends to use recombinant C1-esterase inhibitor or fresh frozen plasma for the acute treatment of hereditary angioedema during the study.
* Received androgen therapy (e.g., danazol, oxandrolone, stanozolol, testosterone) within 30 days before the screening visit.
* Female subjects who started taking or changed dose of any hormonal contraceptive regimen or hormone replacement therapy (i.e., estrogen/progesterone-containing products) within 3 months prior to the screening visit.
* Known or suspected hypersensitivity to the study product, or to any excipients of the study product.
* Pregnancy or lactation.
18 Years
ALL
No
Sponsors
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Parexel
INDUSTRY
CSL Behring
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Program Director
Role: STUDY_DIRECTOR
CSL Behring
Locations
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Study Site
Atlanta, Georgia, United States
Study Site
Chevy Chase, Maryland, United States
Study Site
Cincinnati, Ohio, United States
Study Site
Toledo, Ohio, United States
Study Site
Hershey, Pennsylvania, United States
Study Site
Berlin, , Germany
Study Site
Frankfurt, , Germany
Study Site
Mainz, , Germany
Countries
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References
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Zuraw BL, Cicardi M, Longhurst HJ, Bernstein JA, Li HH, Magerl M, Martinez-Saguer I, Rehman SM, Staubach P, Feuersenger H, Parasrampuria R, Sidhu J, Edelman J, Craig T. Phase II study results of a replacement therapy for hereditary angioedema with subcutaneous C1-inhibitor concentrate. Allergy. 2015 Oct;70(10):1319-28. doi: 10.1111/all.12658. Epub 2015 Aug 11.
Other Identifiers
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2011-005013-36
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CSL830_2001
Identifier Type: -
Identifier Source: org_study_id
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