Evaluation of the Reasons and Consequences of Bleeding in Late Teens and Early Adulthood Patients With Severe Hemophilia A

Study Overview
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Brief Summary
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Understanding how often the bleeding events occur in the subjects who voluntarily decide to switch from prophylaxis to on-demand and in those subjects who remain on prophylaxis. Also look into the consequences of switching treatment in QoL (quality of life), development of target joints, activity level and reasons that might influence the desire to switch.

Official Title
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A Prospective, Non-interventional, Multi-center, Open-label Study to Evaluate the Reasons and Consequences of Bleeding in Late Teens and Early Adulthood Subjects With Severe Hemophilia A Receiving Prophylaxis and On-demand Treatment Regimen

Conditions
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Hematologic Disease, Blood Coagulation Disorders

Intervention / Treatment
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* Behavioral: Recombinant Factor VIII (Kogenate, BAY 14-2222)
* Behavioral: Recombinant Factor VIII (Kogenate, BAY 14-2222)
* Behavioral: Recombinant Factor VIII (Kogenate, BAY 14-2222)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Severe hemophilia A (<2%) For subjects who elect staying on Prophylaxis only: Have been on continuous prophylactic treatment for the past 5 years prior to study entry For subjects who elect switching to on-demand only: Have been on continuous prophylactic treatment for the past 5 years, but may have been on intermediate or reduced prophylaxis for the 1-12 months prior to study entry For subjects currently on-demand: a retrospective arm of subjects who have been on continuous prophylactic treatment for at least 5 years and switched to on-demand treatment between 13 and 24 months prior to study entry Current treatment with rFVIII Exclusion Criteria: Other known hematological / bleeding disorders other than hemophilia A Participating on another study that may have an impact on bleeding or the objectives of this study Known alcohol and drug abuse

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 29 Years

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 |
| --- | --- |
| Group 1<br> | Behavioral: Recombinant Factor VIII (Kogenate, BAY 14-2222)<br>* Subjects electing to stay on the prophylactic treatment (prospective)<br>|
| Group 2<br> | Behavioral: Recombinant Factor VIII (Kogenate, BAY 14-2222)<br>* Subjects electing to switch to on-demand treatment (prospective)<br>|
| Group 3<br> | Behavioral: Recombinant Factor VIII (Kogenate, BAY 14-2222)<br>* Subjects remaining on-demand treatment (retrospective)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the frequency of all bleeds (spontaneous and trauma) during the study |  | End of Study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the change from baseline in HRQoL (health-related quality of life) |  | End of Study | 
| To evaluate number of patients that want to return to prophylaxis treatment after having switched to on-demand therapy |  | End of Study | 
| To evaluate the change from baseline in the Gilbert score |  | End of Study | 
| To evaluate the number of target joint development |  | End of Study |