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This 6-month prospective outcomes study addresses the association between timing of infusion, patient activity levels, and bleeding episodes through patient-reported measurements.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ADVATE (Factor VIII) | Participants will remain on their current (pre-study) treatment regimen of ADVATE throughout the study period |
| |
| RIXUBIS (Factor IX) | Participants will remain on their current (pre-study) treatment regimen of RIXUBIS throughout the study period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ADVATE (Antihemophilic Factor [Recombinant]) | Biological |
|
| |
| 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 |
| 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 |
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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:
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Hemophilia treatment center (HTCs) in the US will be identified and invited to enroll eligible patients in this study
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orthopaedic Hospital DBA Orthopaedic Hemophilia Treatment Center | Los Angeles | California | 90007 | United States | ||
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| Label | URL |
|---|---|
| To obtain more information on the study, click here/on this link. | View source |
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| RIXUBIS (Coagulation Factor IX [Recombinant]) |
| Biological |
|
| 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 |
| Rady Childrens Hospital |
| San Diego |
| California |
| 92123 |
| United States |
| University of Colorado | Aurora | Colorado | 80045 | United States |
| Bleeding and Clotting Disorders Institute | Peoria | Illinois | 61615 | United States |
| University of Kentucky Medical Center | Lexington | Kentucky | 40504 | United States |
| Johns Hopkins University School Of Medicine | Baltimore | Maryland | 21205 | United States |
| Childrens Hospital of Michigan | Detroit | Michigan | 48201 | United States |
| Michigan State University | East Lansing | Michigan | 48823 | United States |
| Munson Medical Center | Traverse City | Michigan | 49684 | United States |
| Children's Mercy Hospitals & Clinics | Kansas City | Missouri | 64108 | United States |
| North Shore/Long Island Jewish PRIME | Great Neck | New York | 11021 | United States |
| The Presbyterian Hospital | Charlotte | North Carolina | 28210 | United States |
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| The Vanderbilt Clinic | Nashville | Tennessee | 37232 | United States |
| The University of Texas MD Anderson | Harlingen | Texas | 78550 | United States |
| Puget Sound Blood Center | Seattle | Washington | 98104 | United States |
| ID | Term |
|---|---|
| D006467 | Hemophilia A |
| D002836 | Hemophilia B |
| ID | Term |
|---|---|
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D040181 | Genetic Diseases, X-Linked |
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| ID | Term |
|---|---|
| D005169 | Factor VIII |
| C078147 | F8 protein, human |
| D005164 | Factor IX |
| ID | Term |
|---|---|
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011498 | Protein Precursors |
| D001685 | Biological Factors |
| D004792 | Enzyme Precursors |
| D045762 | Enzymes and Coenzymes |
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