Human Fibrinogen - Pharmacokinetics

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CSL Behring
ClinicalTrials.gov Identifier:
NCT00496262
First received: July 3, 2007
Last updated: September 21, 2011
Last verified: February 2011
  Purpose

This study evaluated the single-dose pharmacokinetics of human fibrinogen concentrate and clot strength (maximum clot firmness [MCF]) in subjects with congenital fibrinogen deficiency. MCF was measured to demonstrate the functional activity of replacement fibrinogen when a fixed dose of human fibrinogen concentrate was administered.


Condition Intervention Phase
Fibrinogen Deficiency
Biological: Human Fibrinogen Concentrate
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pharmacokinetics of Haemocomplettan® P in Subjects With Congenital Fibrinogen Deficiency

Resource links provided by NLM:


Further study details as provided by CSL Behring:

Primary Outcome Measures:
  • Maximum Clot Firmness (MCF) [ Time Frame: Pre-infusion and 1 hour post-infusion ] [ Designated as safety issue: No ]
    MCF is a functional parameter that depends on the activation of coagulation, the fibrinogen content of the sample (in plasma), and the polymerization and crosslinking of the fibrin network. MCF was determined by rotational thromboelastometry (ROTEM) testing.


Secondary Outcome Measures:
  • Terminal Elimination Half-life (t1/2) [ Time Frame: 0.5 hours to 13 days post-infusion ] [ Designated as safety issue: No ]
    t1/2 for fibrinogen activity was determined from samples taken at 12 timepoints during the specified time frame.

  • Maximum Concentration (Cmax) [ Time Frame: Pre-infusion to 13 days post-infusion ] [ Designated as safety issue: No ]
    Cmax for fibrinogen activity was determined from samples taken at 12 timepoints during the specified time frame.

  • Area Under the Concentration-time Curve (AUC) Standardized for 70 mg/kg Body Weight Dose [ Time Frame: Pre-infusion to 13 days post-infusion ] [ Designated as safety issue: No ]
    AUC for fibrinogen activity was determined from samples taken at 12 timepoints during the specified time frame.

  • Clearance (Cl) [ Time Frame: Pre-infusion to 13 days post-infusion ] [ Designated as safety issue: No ]
    Cl for fibrinogen activity was determined from samples taken at 12 timepoints during the specified time frame.

  • Mean Residence Time (MRT) [ Time Frame: Pre-infusion to 13 days post-infusion ] [ Designated as safety issue: No ]
    MRT for fibrinogen activity was determined from samples taken at 12 timepoints during the specified time frame.

  • Volume of Distribution at Steady State (Vss) [ Time Frame: Pre-infusion to 13 days post-infusion ] [ Designated as safety issue: No ]
    Vss for fibrinogen activity was determined from samples taken at 11 timepoints during the specified time frame.

  • Incremental In Vivo Recovery (IVR) [ Time Frame: Pre-infusion to 4 hours post-infusion ] [ Designated as safety issue: No ]
    Maximum fibrinogen activity increase in plasma per mg/kg dosed

  • Classical In Vivo Recovery (IVR) [ Time Frame: Pre-infusion to 4 hours post-infusion ] [ Designated as safety issue: No ]
    Maximum fibrinogen activity increase in plasma times plasma volume per mg/kg dose


Enrollment: 15
Study Start Date: July 2007
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Human Fibrinogen Concentrate Biological: Human Fibrinogen Concentrate
Single intravenous infusion of 70 mg/kg body weight
Other Names:
  • Haemocomplettan® P
  • RiaSTAP

  Eligibility

Ages Eligible for Study:   6 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged ≥ 6 years
  • Documented congenital fibrinogen deficiency: fibrinogen deficiency manifested as afibrinogenemia with plasma fibrinogen activity and antigen at screening undetectable (i.e. < 20 mg/dL)
  • Informed consent signed by subject or legal guardian

Exclusion Criteria:

  • Presence or history of hypersensitivity to Human Fibrinogen Concentrate or human plasma proteins,
  • Presence or history of deep vein thrombosis, pulmonary embolism, or arterial thrombosis
  • Acute bleeding
  • History of esophageal varicose bleeding
  • End stage liver disease (i.e. Child-Pugh score B or C)
  • Planned major surgery with a need for blood transfusion during the PK blood sampling period
  • Polytrauma within 1 year prior to enrollment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00496262

Locations
United States, Colorado
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Aurora, Colorado, United States, 80045
United States, Florida
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St. Petersburg, Florida, United States, 33701
United States, Illinois
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Chicago, Illinois, United States, 60614
United States, Maine
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Scarborough, Maine, United States, 04074-9308
United States, New York
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New York, New York, United States, 10021
United States, Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15232
Italy
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Cagliari, Italy, 09100
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Firenze, Italy, 50134
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Milano, Italy, 20122
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Napoli, Italy, 80122
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Padova, Italy, 35128
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Palermo, Italy, 90134
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Rome, Italy, 00161
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Sassari, Italy, 07100
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Vicenza, Italy, 36100
Sponsors and Collaborators
CSL Behring
Investigators
Study Director: Program Director, Clinical R&D CSL Behring
  More Information

Additional Information:
Publications:
Responsible Party: CSL Behring
ClinicalTrials.gov Identifier: NCT00496262     History of Changes
Other Study ID Numbers: BI3023_2001
Study First Received: July 3, 2007
Results First Received: May 19, 2009
Last Updated: September 21, 2011
Health Authority: United States: Food and Drug Administration
Italy: Ministry of Health

Keywords provided by CSL Behring:
Congenital fibrinogen deficiency
Fibrinogen concentrate
Pharmacokinetics
Thrombelastography

Additional relevant MeSH terms:
Afibrinogenemia
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on April 17, 2014