Clinical trial NCT03603275: Assessing Physician and Hemophilia A Patient Reasons and Expectations for Switching Treatment to Kovaltry & Jivi: A Nested Study Within an Existing Registry
Official title: Assessing Hemophilia A Patient and Physician Reasons and Expectations for Switching Treatment to Kovaltry & Jivi: A Nested Study Within an Existing Registry
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Hemophilia A
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: American Thrombosis and Hemostasis Network
First posted: 2018-07-27
Enrollment: 3
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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:

* Arm A (Prospective): Patients who are switching factor replacement products and will be followed prospectively for 1 year post-switch
* Arm B (Retrospective): Patients who have switched factor replacement products previously (within the past fifty weeks at the time of enrollments and will be followed prospectively until they reach a total of 52 weeks of observation. Historical data will be collected retrospectively for patients who switched prior to study entry.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Patient reported reasons for switching FVIII replacement treatment to Kovaltry or Jivi using a Bayer designed survey
timeFrame: Up to 4 years
measure: Patient expectations of switching FVIII replacement therapy to Kovaltry or Jivi would affect lifestyle/quality of life using a Bayer designed survey
timeFrame: Up to 4 years
measure: Patient expectations when adjusting to the new product after switch using a Bayer designed survey
timeFrame: Up to 4 years
measure: Patient reported root of expectations using a Bayer designed survey
timeFrame: Up to 4 years
measure: Patient reported reasons that would deter them from switching FVIII replacement products using a Bayer designed survey
timeFrame: Up to 4 years
measure: Physicians reported discipline using a Bayer designed survey
timeFrame: Up to 4 years
measure: Physicians reported reasons for switching FVIII replacement treatment to Kovaltry or Jivi using a Bayer designed survey
timeFrame: Up to 4 years
measure: Dosing Regimen (pre/post-switch)
timeFrame: Up to 4 years
measure: Physicians reported reason of newly selected dose/dosing interval using a Bayer designed survey
timeFrame: Up to 4 years
measure: Physicians reported rationale base for new dosing regimen selection using a Bayer designed survey
timeFrame: Up to 4 years
measure: Physicians reported communication about adjustment period when switching using a Bayer designed survey
timeFrame: Up to 4 years
measure: Physicians reported reasons that a provider would not encourage a patient to switch FVIII products using a Bayer designed survey
timeFrame: Up to 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California, San Diego
state: California
city: Aurora
country: United States
facility: University of Colorado Denver Hemophilia and Thrombosis Center
state: Colorado
city: New Haven
country: United States
facility: Yale Hemophilia Treatment Center
state: Connecticut
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
city: Saint Petersburg
country: United States
facility: Johns Hopkins All Children's Hospital
state: Florida
city: Tampa
country: United States
facility: St. Josephs Hemophilia Treatment Center
state: Florida
city: Atlanta
country: United States
facility: Emory / Children's Healthcare of Atlanta
state: Georgia
city: Peoria
country: United States
facility: Bleeding and Clotting Disorders Institute
state: Illinois
city: Indianapolis
country: United States
facility: Indiana Hemophilia and Thrombosis Center IHTC
state: Indiana
city: New Orleans
country: United States
facility: Louisiana Center for Bleeding and Clotting Disorders / Tulane
state: Louisiana
city: Scarborough
country: United States
facility: Maine Hemophilia and Thrombosis Center
state: Maine
city: Baltimore
country: United States
facility: The Johns Hopkins University Hemophilia Treatment Center
state: Maryland
city: Boston
country: United States
facility: Boston Hemophilia Center at Children's Hospital of Boston/Brigham Women's
state: Massachusetts
city: Ann Arbor
country: United States
facility: Univ of Michigan Hemophilia and Coagulation Disorders
state: Michigan
city: East Lansing
country: United States
facility: Michigan State University Center for Bleeding Disorders & Clotting Disorders
state: Michigan
city: Kansas City
country: United States
facility: Children's Mercy Hospital (Kansas City)
state: Missouri
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Comprehensive Hemophilia and Thrombosis Center
state: New Hampshire
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
city: Rochester
country: United States
facility: Mary M. Gooley Hemophilia Center, Inc.
state: New York
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia (CHOP)
state: Pennsylvania
city: Philadelphia
country: United States
facility: Penn Comprehensive Hemophilia and Thrombophilia Program / Hospital UPENN
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Hemophilia Center of Western Pennsylvania
state: Pennsylvania
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
city: Dallas
country: United States
facility: UT Southwestern/Children's Health Dallas
state: Texas
city: Seattle
country: United States
facility: BloodWorks (Puget Sound)
state: Washington
city: Milwaukee
country: United States
facility: Blood Center of Wisconsin, Inc. /Childrens Hosp of Wisconsin
state: Wisconsin
Study officials:
References: