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Human Fibrinogen - Pharmacokinetics

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ClinicalTrials.gov Identifier: NCT00496262
Recruitment Status : Completed
First Posted : July 4, 2007
Results First Posted : July 10, 2009
Last Update Posted : September 15, 2016
Sponsor:
Information provided by (Responsible Party):
CSL Behring

Brief Summary:
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 or disease Intervention/treatment Phase
Fibrinogen Deficiency Biological: Human Fibrinogen Concentrate Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacokinetics of Haemocomplettan® P in Subjects With Congenital Fibrinogen Deficiency
Study Start Date : July 2007
Primary Completion Date : May 2008
Study Completion Date : May 2008


Arm Intervention/treatment
Experimental: Human Fibrinogen Concentrate Biological: Human Fibrinogen Concentrate
Single intravenous infusion of 70 mg/kg body weight
Other Names:
  • Haemocomplettan® P
  • RiaSTAP



Primary Outcome Measures :
  1. Maximum Clot Firmness (MCF) [ Time Frame: Pre-infusion and 1 hour post-infusion ]
    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 :
  1. Terminal Elimination Half-life (t1/2) [ Time Frame: 0.5 hours to 13 days post-infusion ]
    t1/2 for fibrinogen activity was determined from samples taken at 12 timepoints during the specified time frame.

  2. Maximum Concentration (Cmax) [ Time Frame: Pre-infusion to 13 days post-infusion ]
    Cmax for fibrinogen activity was determined from samples taken at 12 timepoints during the specified time frame.

  3. Area Under the Concentration-time Curve (AUC) Standardized for 70 mg/kg Body Weight Dose [ Time Frame: Pre-infusion to 13 days post-infusion ]
    AUC for fibrinogen activity was determined from samples taken at 12 timepoints during the specified time frame.

  4. Clearance (Cl) [ Time Frame: Pre-infusion to 13 days post-infusion ]
    Cl for fibrinogen activity was determined from samples taken at 12 timepoints during the specified time frame.

  5. Mean Residence Time (MRT) [ Time Frame: Pre-infusion to 13 days post-infusion ]
    MRT for fibrinogen activity was determined from samples taken at 12 timepoints during the specified time frame.

  6. Volume of Distribution at Steady State (Vss) [ Time Frame: Pre-infusion to 13 days post-infusion ]
    Vss for fibrinogen activity was determined from samples taken at 11 timepoints during the specified time frame.

  7. Incremental In Vivo Recovery (IVR) [ Time Frame: Pre-infusion to 4 hours post-infusion ]
    Maximum fibrinogen activity increase in plasma per mg/kg dosed

  8. Classical In Vivo Recovery (IVR) [ Time Frame: Pre-infusion to 4 hours post-infusion ]
    Maximum fibrinogen activity increase in plasma times plasma volume per mg/kg dose



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Ages Eligible for Study:   6 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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

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): 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

Additional Information:
Publications:
Responsible Party: CSL Behring
ClinicalTrials.gov Identifier: NCT00496262     History of Changes
Other Study ID Numbers: BI3023_2001
First Posted: July 4, 2007    Key Record Dates
Results First Posted: July 10, 2009
Last Update Posted: September 15, 2016
Last Verified: February 2011

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