The effect of recombinant Factor IX-FIAV in In-vitro thrombin generation in hemophilia A patient samples
Recruiting
- Conditions
- Hemophilia Acoagulation disorder1006447710005330
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 21
Inclusion Criteria
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
- Age 18 years or older hemophilia A patients
- Male sex
- Mentally capable of informed consent
Exclusion Criteria
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
- Prophylactic treatment with FVIII, with less than 48 hours washout period
between dosages of FVIII
- Patients receiving bypassing therapy such as prothrombin complex (FEIBA),
eptacog alfa (NovoSeven) or emicuzimab (HemLibra)
- Any other known hemostatic disorder, inherited or acquired (such as acquired
von Willebrand disease etc*)
- Any known liver disease, leading to acute or chronic liver disfunction and/or
failure
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Thrombin generation parameters (lag time (main parameter), thrombin peak, time<br /><br>to peak, endogenous thrombin potential) following the addition of purified<br /><br>recombinant FIX-FIAV in vitro.</p><br>
- Secondary Outcome Measures
Name Time Method <p>- The correction in clotting capacity (activated Partial Thromboplastin Time,<br /><br>aPTT) following addition of the purified recombinant FIX variant FIX-FIAV to<br /><br>plasma from hemophilia A patients in vitro.<br /><br>- To assess the effect on thrombin generation when combining FIX-FIAV with<br /><br>approved products used to treat hemophilia A (activated prothrombin complex<br /><br>concentrate (FEIBA), activated factor VII (NovoSeven), a bispecific<br /><br>FVIII-mimicking antibody (emicizumab/HemLibra)) will be determined in the<br /><br>plasma from hemophilia A patients in vitro in order to assess potential<br /><br>induction of a prothrombotic state.<br /><br>- Baseline FVIII (chromogenic and one-stage), FIX (chromogenic and one-stage),<br /><br>prothrombin, antithrombin, FX, von Willebrand factor (vWF), FVIII inhibitory<br /><br>antibodies, and clotting capacity.</p><br>