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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CSL Behring
ClinicalTrials.gov Identifier:
NCT01760343
First received: December 24, 2012
Last updated: April 4, 2013
Last verified: April 2013
History of Changes
  Purpose

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 Intervention Phase
Hereditary Angioedema Types I and II
 Biological: Berinert
Biological: CSL830
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by CSL Behring:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • Relative bioavailability of CSL830 versus Berinert - Cmax [ Time Frame: 240 hours ] [ Designated as safety issue: No ]
    Relative bioavailability in terms of maximum concentration (Cmax) of CSL830 versus Berinert

  • Relative bioavailability of CSL830 versus Berinert - AUC [ Time Frame: 240 hours ] [ Designated as safety issue: No ]
    Relative bioavailability in terms of area under the curve from timepoint 0 to infinity (AUC0-∞) of CSL830 versus Berinert


Enrollment: 16
Study Start Date: January 2013
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01760343

Locations
Germany
Study Site
Berlin, Germany
Sponsors and Collaborators
CSL Behring
Investigators
Study Director: Global Clinical Program Director CSL Behring
  More Information

No publications provided

Responsible Party: CSL Behring
ClinicalTrials.gov Identifier: NCT01760343     History of Changes
Other Study ID Numbers: CSL830_1001, 2012-002429-31
Study First Received: December 24, 2012
Last Updated: April 4, 2013
Health Authority: United States: Food and Drug Administration
Germany: Paul-Ehrlich-Institut

Additional relevant MeSH terms:
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
Complement C1 Inactivator Proteins
Complement C1 Inhibitor Protein
Complement C1
Complement C1s
Complement Inactivating Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013