Assessing Physician and Hemophilia A Patient Reasons and Expectations for Switching Treatment to Kovaltry & Jivi: A Nested Study Within an Existing Registry
- Conditions
- Hemophilia A
- Interventions
- Drug: New FVIII products
- Registration Number
- NCT03603275
- Lead Sponsor
- Bayer
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 3
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patient/caregiver of Kovaltry or Jivi New FVIII products Patients who are switching factor replacement products to Kovaltry or Jivi and patients who have switched factor replacement products to Kovaltry or Jivi previously
- Primary Outcome Measures
Name Time Method Physicians reported discipline using a Bayer designed survey Up to 4 years Data from consenting patients will be collected by ATHN
Dosing Regimen (pre/post-switch) Up to 4 years Data from consenting patients will be collected by ATHN
Physicians reported reason of newly selected dose/dosing interval using a Bayer designed survey Up to 4 years Data from consenting patients will be collected by ATHN
Physicians reported rationale base for new dosing regimen selection using a Bayer designed survey Up to 4 years Data from consenting patients will be collected by ATHN
Patient reported reasons that would deter them from switching FVIII replacement products using a Bayer designed survey Up to 4 years Data from consenting patients will be collected by ATHN
Patient reported reasons for switching FVIII replacement treatment to Kovaltry or Jivi using a Bayer designed survey Up to 4 years Data from consenting patients will be collected by ATHN
Patient expectations when adjusting to the new product after switch using a Bayer designed survey Up to 4 years Data from consenting patients will be collected by ATHN
Patient reported root of expectations using a Bayer designed survey Up to 4 years Data from consenting patients will be collected by ATHN
Patient expectations of switching FVIII replacement therapy to Kovaltry or Jivi would affect lifestyle/quality of life using a Bayer designed survey Up to 4 years Data from consenting patients will be collected by ATHN
Physicians reported communication about adjustment period when switching using a Bayer designed survey Up to 4 years Data from consenting patients will be collected by ATHN
Physicians reported reasons that a provider would not encourage a patient to switch FVIII products using a Bayer designed survey Up to 4 years Data from consenting patients will be collected by ATHN
Physicians reported reasons for switching FVIII replacement treatment to Kovaltry or Jivi using a Bayer designed survey Up to 4 years Data from consenting patients will be collected by ATHN
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (27)
Emory / Children's Healthcare of Atlanta
🇺🇸Atlanta, Georgia, United States
Boston Hemophilia Center at Children's Hospital of Boston/Brigham Women's
🇺🇸Boston, Massachusetts, United States
Children's Hospital of Philadelphia (CHOP)
🇺🇸Philadelphia, Pennsylvania, United States
Penn Comprehensive Hemophilia and Thrombophilia Program / Hospital UPENN
🇺🇸Philadelphia, Pennsylvania, United States
Hemophilia Center of Western Pennsylvania
🇺🇸Pittsburgh, Pennsylvania, United States
UT Southwestern/Children's Health Dallas
🇺🇸Dallas, Texas, United States
Maine Hemophilia and Thrombosis Center
🇺🇸Scarborough, Maine, United States
The Johns Hopkins University Hemophilia Treatment Center
🇺🇸Baltimore, Maryland, United States
BloodWorks (Puget Sound)
🇺🇸Seattle, Washington, United States
Children's National Medical Center
🇺🇸Washington, District of Columbia, United States
St. Jude Children's Research Hospital
🇺🇸Memphis, Tennessee, United States
University of Colorado Denver Hemophilia and Thrombosis Center
🇺🇸Aurora, Colorado, United States
Yale Hemophilia Treatment Center
🇺🇸New Haven, Connecticut, United States
St. Josephs Hemophilia Treatment Center
🇺🇸Tampa, Florida, United States
Indiana Hemophilia and Thrombosis Center IHTC
🇺🇸Indianapolis, Indiana, United States
Univ of Michigan Hemophilia and Coagulation Disorders
🇺🇸Ann Arbor, Michigan, United States
Blood Center of Wisconsin, Inc. /Childrens Hosp of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
University of California, San Diego
🇺🇸La Jolla, California, United States
Johns Hopkins All Children's Hospital
🇺🇸Saint Petersburg, Florida, United States
Bleeding and Clotting Disorders Institute
🇺🇸Peoria, Illinois, United States
Michigan State University Center for Bleeding Disorders & Clotting Disorders
🇺🇸East Lansing, Michigan, United States
Dartmouth-Hitchcock Comprehensive Hemophilia and Thrombosis Center
🇺🇸Lebanon, New Hampshire, United States
Mary M. Gooley Hemophilia Center, Inc.
🇺🇸Rochester, New York, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
Weill Cornell Medicine
🇺🇸New York, New York, United States
Children's Mercy Hospital (Kansas City)
🇺🇸Kansas City, Missouri, United States
Louisiana Center for Bleeding and Clotting Disorders / Tulane
🇺🇸New Orleans, Louisiana, United States