Clareo Health | Study Evaluating "Real World" Treatment Pattern in Previously Treated Hemophilia A Patients Receiving KOVALTRY (Octocog Alfa) for Routine Prophylaxis
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bayer
Open label, prospective, non-interventional, single arm study in patients receiving KOVALTRY as prophylaxis therapy.
Age
Any age
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
Male patients diagnosed with moderate to severe hemophilia A (≤ 5% FVIII:C (Factor VIII Coagulant activity))
Any age
≥ 50 exposure days (EDs) to any FVIII product
Patients with or without history of inhibitors
* Patient with previous history of inhibitors, with at least 2 consecutive negative inhibitor tests and on standard prophylaxis therapy for at least 1 year prior to study entry
* No current evidence of FVIII inhibitor or clinical suspicion of FVIII inhibitor
* Evidence of FVIII inhibitor as measured by the Nijmegen-modified Bethesda assay \[\<0.6 Bethesda units (BU/mL)\] or Bethesda assay \[\< 1.0 BU/mL\] in 2 on consecutives samples
* Documented or clinical suspicion of shortened FVIII half-life (\< 6 hrs)
Currently on or plan to start prophylaxis therapy with KOVALTRY
Written informed consent
You may not be if
Patients participating in an investigational program with interventions outside of routine clinical practice
Patients with an additional diagnosis of any bleeding/coagulation disorder other than hemophilia A
Patients on Immune Tolerance Induction (ITI) treatment at the time of enrollment
