Study of Prophylaxis, ACtivity and Effectiveness (SPACE) in Hemophilia Patients Currently Treated With ADVATE or RIXUBIS

Study Overview
=================
Brief Summary
-----------------
This 6-month prospective outcomes study addresses the association between timing of infusion, patient activity levels, and bleeding episodes through patient-reported measurements.

Official Title
-----------------
Study of Prophylaxis, ACtivity and Effectiveness (SPACE) in Hemophilia Patients Currently Treated With ADVATE or RIXUBIS

Conditions
-----------------
Hemophilia A, Hemophilia B

Intervention / Treatment
-----------------
* Biological: ADVATE (Antihemophilic Factor [Recombinant])
* Biological: RIXUBIS (Coagulation Factor IX [Recombinant])


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 13 to 65 years old at the time of screening has moderately severe or severe hemophilia A or B (FVIII/FIX level ≤2%), with or without transient inhibitors Hemophilia A patient currently prescribed ADVATE (FVIII) or Hemophilia B patient currently prescribed RIXUBIS (FIX) previously treated with plasma-derived FVIII/FIX concentrates or recombinant FVIII/FIX for ≥150 documented exposure days (EDs) is willing and able to comply with the requirements of the protocol is proficient in the English language to allow for use of the SPACE eDiary Exclusion Criteria: inhibitor titer ≥0.6 Bethesda units or currently being treated for an inhibitor has participated in another clinical study involving a medicinal product or device within 30 days prior to enrollment or is scheduled to participate in another clinical study involving a medicinal product or device during the course of this study is a family member or employee of the investigator elective major surgery is planned within 6 months after enrollment which may interfere with activities of daily living (at investigator's discretion) continuously require walking assistance devices (eg, wheelchair, crutches, etc.)

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ADVATE (Factor VIII)<br>Participants will remain on their current (pre-study) treatment regimen of ADVATE throughout the study period | Biological: ADVATE (Antihemophilic Factor [Recombinant])<br> <br> * Other names: Octocog alfa;|
| RIXUBIS (Factor IX)<br>Participants will remain on their current (pre-study) treatment regimen of RIXUBIS throughout the study period | Biological: RIXUBIS (Coagulation Factor IX [Recombinant])<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Advancing the understanding of the relationship between patient physical activity levels, infusion and occurrence of bleeding episodes (BEs) | After the informed consent form is signed, retrospective data on physical activity levels, infusion and occurrence of BEs will be collected. The retrospective period will be the 6 months prior to signing the ICF. | 6 months retrospectively (after the informed consent form (ICF) is signed) through 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Types of current physical activities of participants |  | Baseline through 6 months | 
| Activity measurement | Including: calories burned, steps taken, distance traveled, and active minutes | Baseline through 6 months | 
| Infusion schedule for participants on prophylaxis |  | Baseline through 6 months | 
| Infusion amount (either ADVATE (Hemophilia A), or RIXUBIS (Hemophilia B) |  | Baseline through 6 months | 
| Occurrence of bleeding episodes (BEs) | After the informed consent form is signed, retrospective data on physical activity levels, infusion and occurrence of BEs will be collected. The retrospective period will be the 6 months prior to signing the ICF. | 6 months retrospectively (after the informed consent form (ICF) is signed) through 6 months | 
| Patient-reported outcome: Hemophilia Activities List (HAL) questionnaire - for adult patients | The HAL measures activities involving the upper extremities, basic activities involving the lower extremities and complex activities involving the lower extremities as well as an overall physical activity score for adults. | Baseline and 6 months | 
| Patient-reported outcome: pediatric Hemophilia Activities List (pedHAL) questionnaire - for pediatric patients | The PedHAL measures activities involving the upper extremities, basic activities involving the lower extremities and complex activities involving the lower extremities as well as an overall physical activity score for participants 13-17 years of age: | Baseline and 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Factor VIII Deficiency, Factor FIX Deficiency