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Blood factor monitoring assay and uses thereof

  • US 10,001,495 B2
  • Filed: 07/25/2013
  • Issued: 06/19/2018
  • Est. Priority Date: 07/25/2012
  • Status: Active Grant
First Claim
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1. A method of treating a bleeding disorder in a patient in need thereof comprising:

  • a) measuring the time between contacting of a sample obtained from the patient with an activation mixture dried on a solid substrate and the onset of clotting, thereby calculating the clotting time (Ct),wherein the activation mixture comprises (i) an activated Factor IX (FIXa) and (ii) a phospholipid mixture,wherein the Ct is used to determine a pharmacokinetic (PK) parameter of a coagulation factor, wherein the coagulation factor comprises a Factor VIII (FVIII),wherein the PK parameter is a terminal half-life (HL) or a time to trough (T),wherein the HL is calculated according to the following formula;


    HL=−

    0.693×

    (T2

    T
    1

    A/(Ct1

    Ct2),wherein A is a constant value corresponding to the slope of a Ct versus coagulation factor concentration dose-response, T1 and T2 are times at which Ct is measured, and Ct1 and Ct2 are Ct values measured at T1 and T2, respectively,wherein the T is calculated according to the following formula;


    T=−

    1.44×

    HL/(A×

    (Ctmeasured

    Cttrough),wherein A is a constant value corresponding to the slope of a Ct versus coagulation factor concentration dose-response, and HL is the terminal half-life, Ctmeasured is Ct measured at certain time point, and Cttrough is patient-specific clot time at trough, andb) administering an effective amount of the coagulation factor at a dosing interval based on the PK parameter.

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