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NCT03603275 Clinical Trial

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

Hemophilia A Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT03603275
Other study ID # 19866
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date August 6, 2018
Est. completion date May 14, 2020

Study information
Verified date August 2022
Source Bayer
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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 information / eligibility
Status Terminated
Enrollment 3
Est. completion date May 14, 2020
Est. primary completion date May 14, 2020
Accepts healthy volunteers No
Gender All
Age group 2 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• New FVIII products
Kovaltry or Jivi prescribed by the treating Physician

Locations
Country Name City State
United States Univ of Michigan Hemophilia and Coagulation Disorders Ann Arbor Michigan
United States Emory / Children's Healthcare of Atlanta Atlanta Georgia
United States University of Colorado Denver Hemophilia and Thrombosis Center Aurora Colorado
United States The Johns Hopkins University Hemophilia Treatment Center Baltimore Maryland
United States Boston Hemophilia Center at Children's Hospital of Boston/Brigham Women's Boston Massachusetts
United States UT Southwestern/Children's Health Dallas Dallas Texas
United States Michigan State University Center for Bleeding Disorders & Clotting Disorders East Lansing Michigan
United States Indiana Hemophilia and Thrombosis Center IHTC Indianapolis Indiana
United States Children's Mercy Hospital (Kansas City) Kansas City Missouri
United States University of California, San Diego La Jolla California
United States Dartmouth-Hitchcock Comprehensive Hemophilia and Thrombosis Center Lebanon New Hampshire
United States St. Jude Children's Research Hospital Memphis Tennessee
United States Blood Center of Wisconsin, Inc. /Childrens Hosp of Wisconsin Milwaukee Wisconsin
United States Yale Hemophilia Treatment Center New Haven Connecticut
United States Louisiana Center for Bleeding and Clotting Disorders / Tulane New Orleans Louisiana
United States Weill Cornell Medicine New York New York
United States Bleeding and Clotting Disorders Institute Peoria Illinois
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 Oregon Health & Science University Portland Oregon
United States Mary M. Gooley Hemophilia Center, Inc. Rochester New York
United States Johns Hopkins All Children's Hospital Saint Petersburg Florida
United States Maine Hemophilia and Thrombosis Center Scarborough Maine
United States BloodWorks (Puget Sound) Seattle Washington
United States St. Josephs Hemophilia Treatment Center Tampa Florida
United States Children's National Medical Center Washington District of Columbia

Sponsors (2)
Lead Sponsor Collaborator
Bayer American Thrombosis and Hemostasis Network

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary Patient reported root of expectations using a Bayer designed survey Data from consenting patients will be collected by ATHN Up to 4 years
Primary 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
Primary Physicians reported discipline using a Bayer designed survey Data from consenting patients will be collected by ATHN Up to 4 years
Primary 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
Primary Dosing Regimen (pre/post-switch) Data from consenting patients will be collected by ATHN Up to 4 years
Primary 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
Primary 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
Primary 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
Primary 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
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