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

Study Overview
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Brief Summary
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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.

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

Official Title
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A Multinational Phase IV Study Evaluating Real World Treatment Pattern in Previously Treated Hemophilia A Patients Receiving KOVALTRY (Octocog Alfa) for Routine Prophylaxis

Conditions
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Hemophilia A, Congenital

Intervention / Treatment
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* Biological: Kovaltry (Antihemophilic Factor [Recombinant], BAY81-8973


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| BAY81-8973<br>Previously treated patients receiving IV infusion of KOVALTRY for routine prophylaxis | Biological: Kovaltry (Antihemophilic Factor [Recombinant], BAY81-8973<br>* unmodified, full length recombinant FVIII<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients on 2x and 3x weekly prophylaxis at end of observation period |  | Up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Annualized composite number of reported bleeds (total, spontaneous, joint and trauma) |  | Up to 2 years | 
| Proportion of patients in predefined prophylaxis regimen per age group and per country | Age group: 0 to <6, ≥6 to <12, ≥12 to <18, 18 and above Weekly prophylaxis dosing regimens: 2 injections a week 3 injections a week Injected on every other day | At the end of observational period, up to 2 years | 
| Physician decision determinants of prophylaxis regimen | Age i.v. access Current treatment regimen Bleeding history with current treatment regimen Prior history of life threatening bleed Number of target joints Pharmacokinetic data Adherence/Compliance history Activity level Patient/caregiver preference Caregiver support Insurance coverage (US) Institution guidelines Country guidelines Other | At baseline | 
| Change from baseline to one year and two years in treatment satisfaction (Hemo-SAT) | Hemo-SAT - Hemophilia treatment satisfaction questionnaire | At baseline, 1 year and end of observational period, up to 2 years | 
| Change from baseline to six months, one year and two years in Validated Hemophilia Regimen Treatment Adherence Scale-Prophylaxis (VERITAS-PRO) | VERITAS - Validated Hemophilia Regimen Treatment Adherence Scale-Prophylaxis | At baseline, 6 months and end of observational period, up to 2 years | 
| Incidence of adverse events (AEs) and serious adverse events (SAEs) |  | Up to 2 years | 
| Type of data relating to KOVALTRY PK | Pharmacokinectic (PK) parameters Area under the curve (AUC) Clearance (Cl) Half-life FVIII trough FVIII peak levels In-vivo recovery | At routine visits, up to 2 years | 
| The total annualized factor consumption (injections) |  | Up to 2 years | 
| Change in prophylaxis dosing frequency (study start to end of observation period) |  | At baseline and end of observation period, up to 2 years | 
| Reasons for selection of initial dose / dosing frequency of Kovaltry (study start to end of observation period) |  | At baseline and end of observation period, up to 2 years | 
| Number of KOVALTRY PK assessments performed |  | At routine visits, up to 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Previously treated patients