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Completed

NCT Number: NCT00496262

Human Fibrinogen - Pharmacokinetics

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.

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Key information

Conditions

Fibrinogen Deficiency Afibrinogenemia Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders

Age range

6 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Contact CSL Behring for facility details, Cagliari, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Human Fibrinogen Concentrate

Biological

Single intravenous infusion of 70 mg/kg body weight

Other names: Haemocomplettan® P, RiaSTAP

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

CSL Behring

Industry

Registry information

Official study title

Pharmacokinetics of Haemocomplettan® P in Subjects With Congenital Fibrinogen Deficiency

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jul 4, 2007
Registry last updated
Sep 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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