Study Evaluating Pharmacovigilance Of Refacto AF

Study Overview
=================
Brief Summary
-----------------
The purpose of this observational study is to describe the incidence of adverse events among patients treated with Refacto AF in usual health care settings in Germany and Austria.

Detailed Description
-----------------
Non-interventional study: subjects to be selected according to the usual clinical practice of their physician

Official Title
-----------------
Pharmacovigilance Evaluation Of Refacto Af (Registered) In Germany And Austria

Conditions
-----------------
Hemophilia A

Intervention / Treatment
-----------------
* Drug: ReFacto AF (Moroctocog alfa)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with hemophilia A of any severity already receiving or starting treatment with ReFacto AF. Exclusion Criteria: Patients with Hemophilia A treated with a product other than Refacto AF.
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Patients treated with Refacto AF | Drug: ReFacto AF (Moroctocog alfa)<br>* Patients will be treated with intravenous infusion of ReFacto AF per dosing and frequency as prescribed by the subjects' treating physician. ReFacto AF® will be prescribed in the context of routine clinical practice in Germany and Austria, respectively<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability or incapacity; cancer; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to last visit (up to 87 months) that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events. | Baseline until last visit (up to 87 months) | 
| Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) | Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; cancer; congenital anomaly. AEs included both serious and non-serious adverse events. Relatedness of AEs with Refacto AF was assessed by the investigator. | Baseline until last visit (up to 87 months) | 
| Number of Participants With Factor VIII (FVIII) Inhibitor Development as Measured by the Nijmegen-Modified Bethesda Assay | FVIII inhibitor development was defined as measured inhibitor titer of greater than (>) 0.6 Bethesda Units (BU) using the Nijmegen-modified Bethesda assay. | Baseline until last visit (up to 87 months) | 
| Mean Total Number of Bleeding Episodes in Participants | Participants documented all bleeding episodes in a diary during the study. | Baseline until last visit (up to 87 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Total Number of Bleeding Episodes Per Year in Participants | Participants documented all bleeding episodes in a diary during the study. Mean total number of bleeding episodes per year was calculated as: mean total number of bleeding episodes divided by duration of observation period (in years) for bleeding documentation. | Baseline until last visit (up to 87 months) | 
| Number of Participants With Change From Baseline Status in Days Missed From School or Work | Change from baseline status in days missed from school or work was categorized in 3 categories: Improvement, unchanged and worsening. Improvement defined as a decrease in number of days missed by participants from school/work as compared to baseline; worsening was defined as an increase in number of days missed by participants from school/work as compared to baseline; unchanged was defined as no change in number of days missed by participants from school/work as compared to baseline. In this outcome measure, number of participants with change from baseline status (as improved, worsen, unchanged) in days missed from school/work were reported. | Baseline until last visit (up to 87 months) | 
| Participant Assessment of Satisfaction With Treatment Handling | Participants evaluated their satisfaction with handing (administration) of Refacto AF and rated it in 4 categories as: very satisfied, satisfied, unsatisfied and very unsatisfied. | End of study visit (any time up to 87 months) | 
| Investigator Assessment of Treatment Satisfaction of Participants | Investigator assessed the treatment satisfaction of participants and categorized as very satisfied, satisfied, unsatisfied, or very unsatisfied. | End of study visit (any time up to 87 months) |