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| Name | Class |
|---|---|
| American Thrombosis and Hemostasis Network | NETWORK |
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This US study aims to assess hemophilia A patient characteristics and reasons for switching from both patient/caregiver and physician perspectives. For this purpose, this research study will include hemophilia A patients who have switched from an existing therapy to Kovaltry or Jivi. In doing so, real world evidence will be obtained from both patient and physician perspectives offering key insights for effective therapeutic management of patients with hemophilia A and to more fully understand what drives patient switching from a patient perspective and a physician perspective.
This observational study consists of a patient and a physician survey. This survey will consist of questions developed by Bayer and submitted to the Steering Committee of the existing registry, ATHN-2. Once enrolled to participate in the ATHN-2 registry and provided consent to participate in the Bayer nested study, patients who have switched from another product to Kovaltry or Jivi within the past 50 weeks or at the time of enrollment will be prompted to answer the additional survey questions.
Conclusion of the ATHN-2 registry is scheduled for 2021. Once data is cleaned and locked by the registry, the data will be delivered to Bayer for conduct of our analyses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient/caregiver of Kovaltry or Jivi | Patients who are switching factor replacement products to Kovaltry or Jivi and patients who have switched factor replacement products to Kovaltry or Jivi previously |
| |
| Physician Group | Physicians participating in the study are associated with US hemophilia treatment centers that are affiliated with the ATHN hemophilia treatment center network |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| New FVIII products | Drug | Kovaltry or Jivi prescribed by the treating Physician |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient reported reasons for switching FVIII replacement treatment to Kovaltry or Jivi using a Bayer designed survey | Data from consenting patients will be collected by ATHN | Up to 4 years |
| Patient expectations of switching FVIII replacement therapy to Kovaltry or Jivi would affect lifestyle/quality of life using a Bayer designed survey | Data from consenting patients will be collected by ATHN | Up to 4 years |
| Patient expectations when adjusting to the new product after switch using a Bayer designed survey | Data from consenting patients will be collected by ATHN | Up to 4 years |
| Patient reported root of expectations using a Bayer designed survey | Data from consenting patients will be collected by ATHN | Up to 4 years |
| Patient reported reasons that would deter them from switching FVIII replacement products using a Bayer designed survey | Data from consenting patients will be collected by ATHN | Up to 4 years |
| Physicians reported discipline using a Bayer designed survey | Data from consenting patients will be collected by ATHN | Up to 4 years |
| Physicians reported reasons for switching FVIII replacement treatment to Kovaltry or Jivi using a Bayer designed survey | Data from consenting patients will be collected by ATHN |
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Hemophilia A patients who have switched treatment to treatment with Kovaltry or Jivi within the past 50 weeks, who are enrolled the ATHN 2: Factor Switching Study, and who have consented to participate in the Kovaltry or Jivi specific module will be included in this study.
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Previously treated hemophilia A patients enrolled into existing registry who have switched FVIII replacement treatment to Kovaltry or Jivi and provided consent to participate in the Bayer nested study
ATHN's study with categorize selected subjects into two arms:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Diego | La Jolla | California | 92093 | United States | ||
| University of Colorado Denver Hemophilia and Thrombosis Center |
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| Up to 4 years |
| Dosing Regimen (pre/post-switch) | Data from consenting patients will be collected by ATHN | Up to 4 years |
| Physicians reported reason of newly selected dose/dosing interval using a Bayer designed survey | Data from consenting patients will be collected by ATHN | Up to 4 years |
| Physicians reported rationale base for new dosing regimen selection using a Bayer designed survey | Data from consenting patients will be collected by ATHN | Up to 4 years |
| Physicians reported communication about adjustment period when switching using a Bayer designed survey | Data from consenting patients will be collected by ATHN | Up to 4 years |
| Physicians reported reasons that a provider would not encourage a patient to switch FVIII products using a Bayer designed survey | Data from consenting patients will be collected by ATHN | Up to 4 years |
| Aurora |
| Colorado |
| 80045 |
| United States |
| Yale Hemophilia Treatment Center | New Haven | Connecticut | 06510 | United States |
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010 | United States |
| Johns Hopkins All Children's Hospital | St. Petersburg | Florida | 33701 | United States |
| St. Josephs Hemophilia Treatment Center | Tampa | Florida | 33607 | United States |
| Emory / Children's Healthcare of Atlanta | Atlanta | Georgia | 30322 | United States |
| Bleeding and Clotting Disorders Institute | Peoria | Illinois | 61615 | United States |
| Indiana Hemophilia and Thrombosis Center IHTC | Indianapolis | Indiana | 46260 | United States |
| Louisiana Center for Bleeding and Clotting Disorders / Tulane | New Orleans | Louisiana | 70112 | United States |
| Maine Hemophilia and Thrombosis Center | Scarborough | Maine | 04074 | United States |
| The Johns Hopkins University Hemophilia Treatment Center | Baltimore | Maryland | 21205 | United States |
| Boston Hemophilia Center at Children's Hospital of Boston/Brigham Women's | Boston | Massachusetts | 02115 | United States |
| Univ of Michigan Hemophilia and Coagulation Disorders | Ann Arbor | Michigan | 48109 | United States |
| Michigan State University Center for Bleeding Disorders & Clotting Disorders | East Lansing | Michigan | 48824 | United States |
| Children's Mercy Hospital (Kansas City) | Kansas City | Missouri | 64108 | United States |
| Dartmouth-Hitchcock Comprehensive Hemophilia and Thrombosis Center | Lebanon | New Hampshire | 03756 | United States |
| Weill Cornell Medicine | New York | New York | 10065 | United States |
| Mary M. Gooley Hemophilia Center, Inc. | Rochester | New York | 14621 | United States |
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| Children's Hospital of Philadelphia (CHOP) | Philadelphia | Pennsylvania | 01914 | United States |
| Penn Comprehensive Hemophilia and Thrombophilia Program / Hospital UPENN | Philadelphia | Pennsylvania | 19104 | United States |
| Hemophilia Center of Western Pennsylvania | Pittsburgh | Pennsylvania | 15213 | United States |
| St. Jude Children's Research Hospital | Memphis | Tennessee | 38105 | United States |
| UT Southwestern/Children's Health Dallas | Dallas | Texas | 75390 | United States |
| BloodWorks (Puget Sound) | Seattle | Washington | 98104 | United States |
| Blood Center of Wisconsin, Inc. /Childrens Hosp of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| ID | Term |
|---|---|
| D006467 | Hemophilia A |
| 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 |
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