The effect of recombinant Factor IX-FIAV in In-vitro thrombin generation in hemophilia A patient samples

The effect of recombinant Factor IX-FIAV in In-vitro thrombin generation in hemophilia A patient samples - FIVITAS

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON47946

Enrollment

Registered

2019-12-04

Start date

2019-12-24

Completion date

Unknown

Last updated

2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemophilia A

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Thrombin generation parameters (lag time (main parameter), thrombin peak, time to peak, endogenous thrombin potential) following the addition of purified recombinant FIX-FIAV in vitro.	—

Secondary

Measure	Time frame
- The correction in clotting capacity (activated Partial Thromboplastin Time, aPTT) following addition of the purified recombinant FIX variant FIX-FIAV to plasma from hemophilia A patients in vitro. - To assess the effect on thrombin generation when combining FIX-FIAV with approved products used to treat hemophilia A (activated prothrombin complex concentrate (FEIBA), activated factor VII (NovoSeven), a bispecific FVIII-mimicking antibody (emicizumab/HemLibra)) will be determined in the plasma from hemophilia A patients in vitro in order to assess potential induction of a prothrombotic state. - Baseline FVIII (chromogenic and one-stage), FIX (chromogenic and one-stage), prothrombin, antithrombin, FX, von Willebrand factor (vWF), FVIII inhibitory antibodies, and clotting capacity.	—

Measure

Time frame

- The correction in clotting capacity (activated Partial Thromboplastin Time, aPTT) following addition of the purified recombinant FIX variant FIX-FIAV to plasma from hemophilia A patients in vitro. - To assess the effect on thrombin generation when combining FIX-FIAV with approved products used to treat hemophilia A (activated prothrombin complex concentrate (FEIBA), activated factor VII (NovoSeven), a bispecific FVIII-mimicking antibody (emicizumab/HemLibra)) will be determined in the plasma from hemophilia A patients in vitro in order to assess potential induction of a prothrombotic state. - Baseline FVIII (chromogenic and one-stage), FIX (chromogenic and one-stage), prothrombin, antithrombin, FX, von Willebrand factor (vWF), FVIII inhibitory antibodies, and clotting capacity.

—

Countries

Netherlands

Outcome results