Study Evaluating "Real World" Treatment Pattern in Previously Treated Hemophilia A Patients Receiving KOVALTRY (Octocog Alfa) for Routine Prophylaxis (TAURUS)

Bayer

Status: Completed

Conditions: Hemophilia A, Congenital

Treatments: Biological: Kovaltry (Antihemophilic Factor [Recombinant], BAY81-8973

Study type: Observational

Funder types: Industry

Identifiers

NCT02830477

KV1601 (Other Identifier)

18559

Details and patient eligibility

About

The primary objective of this study is to investigate weekly prophylaxis dosing regimens used in standard clinical practice.

In addition the study will capture reported bleed rate, pattern of change in KOVALTRY prophylaxis dose & dosing frequency, reason for choice of treatment regimen, FVIII product switch pattern, patient treatment satisfaction and adherence, KOVALTRY pharmacokinetic data (if performed), KOVALTRY consumption, as well as safety data.

Full description

Open label, prospective, non-interventional, single arm study in patients receiving KOVALTRY as prophylaxis therapy.

Enrollment: 313 patients

Sex: Male

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

313 participants in 1 patient group

BAY81-8973

Description:

Previously treated patients receiving IV infusion of KOVALTRY for routine prophylaxis

Treatment:

Biological: Kovaltry (Antihemophilic Factor [Recombinant], BAY81-8973