Assessing Physician and Hemophilia A Patient Reasons and Expectations for Switching Treatment to Kovaltry & Jivi: A Nested Study Within an Existing Registry

Assessing Hemophilia A Patient and Physician Reasons and Expectations for Switching Treatment to Kovaltry & Jivi: A Nested Study Within an Existing Registry

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.

Study Overview

• Status: Terminated
• Conditions: Hemophilia A
• Intervention / Treatment: Drug: New FVIII products

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.

• Study Type: Observational
• Enrollment (Actual): 3

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92093
      • University of California, San Diego
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Denver Hemophilia and Thrombosis Center
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale Hemophilia Treatment Center
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Children's National Medical Center
  • Florida
    • Saint Petersburg, Florida, United States, 33701
      • Johns Hopkins All Children's Hospital
    • Tampa, Florida, United States, 33607
      • St. Josephs Hemophilia Treatment Center
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory / Children's Healthcare of Atlanta
  • Illinois
    • Peoria, Illinois, United States, 61615
      • Bleeding and Clotting Disorders Institute
  • Indiana
    • Indianapolis, Indiana, United States, 46260
      • Indiana Hemophilia and Thrombosis Center IHTC
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Louisiana Center for Bleeding and Clotting Disorders / Tulane
  • Maine
    • Scarborough, Maine, United States, 04074
      • Maine Hemophilia and Thrombosis Center
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • The Johns Hopkins University Hemophilia Treatment Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Boston Hemophilia Center at Children's Hospital of Boston/Brigham Women's
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Univ of Michigan Hemophilia and Coagulation Disorders
    • East Lansing, Michigan, United States, 48824
      • Michigan State University Center for Bleeding Disorders & Clotting Disorders
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • Children's Mercy Hospital (Kansas City)
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth-Hitchcock Comprehensive Hemophilia and Thrombosis Center
  • New York
    • New York, New York, United States, 10065
      • Weill Cornell Medicine
    • Rochester, New York, United States, 14621
      • Mary M. Gooley Hemophilia Center, Inc.
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 01914
      • Children's Hospital of Philadelphia (CHOP)
    • Philadelphia, Pennsylvania, United States, 19104
      • Penn Comprehensive Hemophilia and Thrombophilia Program / Hospital UPENN
    • Pittsburgh, Pennsylvania, United States, 15213
      • Hemophilia Center of Western Pennsylvania
  • Tennessee
    • Memphis, Tennessee, United States, 38105
      • St. Jude Children's Research Hospital
  • Texas
    • Dallas, Texas, United States, 75390
      • UT Southwestern/Children's Health Dallas
  • Washington
    • Seattle, Washington, United States, 98104
      • BloodWorks (Puget Sound)
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Blood Center of Wisconsin, Inc. /Childrens Hosp of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Drug: New FVIII products; Kovaltry or Jivi prescribed by the treating Physician
Physician Group; Physicians participating in the study are associated with US hemophilia treatment centers that are affiliated with the ATHN hemophilia treatment center network

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Bayer
• Collaborators: American Thrombosis and Hemostasis Network

Publications and helpful links

Helpful Links

• Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 6, 2018
• Primary Completion (ACTUAL): May 14, 2020
• Study Completion (ACTUAL): May 14, 2020

Study Registration Dates

• First Submitted: July 20, 2018
• First Submitted That Met QC Criteria: July 20, 2018
• First Posted (ACTUAL): July 27, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 25, 2022
• Last Update Submitted That Met QC Criteria: August 23, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Blood Coagulation Disorders, Inherited; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Blood Coagulation Disorders; Hemophilia A
• Other Study ID Numbers: 19866

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No