Version Testing of EnzySystem Version A for Hemophilia A

SuspendedOBSERVATIONAL
Enrollment

40

Participants

Timeline

Start Date

May 29, 2024

Primary Completion Date

March 1, 2026

Study Completion Date

May 1, 2026

Conditions
Hemophilia A
Interventions
DIAGNOSTIC_TEST

Several assays

Standard blood draw by venipuncture is performed in all study participants to collect blood samples in four 2.7 mL citrated blood tubes. Tube one is a dummy tube and is discarded. Tube two is used for the FVIII activity and thrombin generation assay on the EnzySystem. Tube three is used to perform conventional FVIII activity and thrombin generation assays. Tube four is used for duplicate measurements of the conventional assays and measurement of prothrombin F1+2 antigen levels, ADAMTS13 activity, FVIII antigen, VWF (von Willebrand Factor) antigen and von Willebrand ristocetin cofactor activity levels.

Trial Locations (2)

Unknown

Enzyre BV, Nijmegen

6525 GA

Radboud university medical center, Nijmegen

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Enzyre B.V.

INDUSTRY

lead

Radboud University Medical Center

OTHER

NCT06273865 - Version Testing of EnzySystem Version A for Hemophilia A | Biotech Hunter | Biotech Hunter