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A Study to Evaluate the Safety and Pharmacokinetics of Two Formulations of C1-esterase Inhibitor

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: NCT01760343
Recruitment Status : Completed
First Posted : January 4, 2013
Last Update Posted : April 5, 2013
Sponsor:
Information provided by (Responsible Party):
CSL Behring

Study Description
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Brief Summary:
A new formulation of Berinert (CSL830) is being investigated for the management of hereditary angioedema (HAE). The main aim of the study is to assess the safety of a single 1500 IU dose of the new formulation of Berinert. This study will also look at the pharmacokinetics of CSL830 relative to Berinert currently on the market.

Condition or disease Intervention/treatment Phase
Hereditary Angioedema Types I and II Biological: Berinert Biological: CSL830 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Single-center, Cross-over Study to Evaluate the Safety, Bioavailability and Pharmacokinetics of Two Formulations of C1-esterase Inhibitor Administered Intravenously
Study Start Date : January 2013
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Berinert, then CSL830
A single intravenous dose of Berinert at 1500 units (1500 IU), followed by a single intravenous dose of CSL830 at 1500 IU.
 Biological: Berinert
Berinert is a plasma-derived C1 esterase inhibitor (human), supplied as a freeze-dried powder for reconstitution.

Biological: CSL830
CSL830 is a formulation of Berinert.
Experimental: CSL830, then Berinert
A single intravenous dose of CSL830 at 1500 IU, followed by a single intravenous dose of Berinert at 1500 IU.
 Biological: Berinert
Berinert is a plasma-derived C1 esterase inhibitor (human), supplied as a freeze-dried powder for reconstitution.

Biological: CSL830
CSL830 is a formulation of Berinert.


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of adverse events (AEs) within 24 hours of CSL830 infusion [ Time Frame: From the start of infusion to 24 hours after the end of infusion ]

Secondary Outcome Measures :
  1. Incidence of adverse events (AEs) within 10 days of the CSL830 infusion [ Time Frame: From the start of infusion to 10 days after the infusion ]
  2. Relative bioavailability of CSL830 versus Berinert - Cmax [ Time Frame: 240 hours ]
    Relative bioavailability in terms of maximum concentration (Cmax) of CSL830 versus Berinert

  3. Relative bioavailability of CSL830 versus Berinert - AUC [ Time Frame: 240 hours ]
    Relative bioavailability in terms of area under the curve from timepoint 0 to infinity (AUC0-∞) of CSL830 versus Berinert


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy subjects without clinically significant medical conditions or laboratory abnormalities
  • Male or female subjects aged 18 to 45 years inclusive, at the time of informed consent
  • Non-smokers
  • Body mass index of 18.0 to 29.0 kg/m2 inclusive

Exclusion Criteria:

  • Previous history of clinically significant arterial or venous thrombosis, current history of a clinically significant pro-thrombotic risk, or a clinically significant abnormality on laboratory thrombotic screen at the screening visit.
  • Known or suspected hypersensitivity to the investigational medicinal product (IMP), or to any excipients of the IMP.
  • Female subjects who started taking or changed dose of any hormonal contraceptive regimen or hormone replacement therapy (ie, estrogen/progesterone containing products) within 3 months before the screening visit.
  • Alcohol, drug, or medication abuse within one year before the study.
  • Female subjects of childbearing potential (eg, not post-menopausal) either not using, or not willing to use, a medically reliable method of contraception for the entire duration of the study, or have a vasectomized partner, or not sexually abstinent for the entire duration of the study, or not surgically sterile.
  • Participation in another clinical study (or use of another IMP) within 30 days (or 5 times the half-life, whichever is longer) before, or during, the study.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01760343


Locations
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Germany
Study Site
Berlin, Germany
Sponsors and Collaborators
CSL Behring
Investigators
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Study Director: Global Clinical Program Director CSL Behring
More Information
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Responsible Party: CSL Behring
ClinicalTrials.gov Identifier: NCT01760343    
Other Study ID Numbers: CSL830_1001
2012-002429-31 ( EudraCT Number )
First Posted: January 4, 2013    Key Record Dates
Last Update Posted: April 5, 2013
Last Verified: April 2013
Additional relevant MeSH terms:
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Angioedema
Angioedemas, Hereditary
Hereditary Angioedema Types I and II
Vascular Diseases
Cardiovascular Diseases
Urticaria
 Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Genetic Diseases, Inborn