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

Sponsor

Bayer (Industry)

Overall Status

Terminated

CT.gov ID

NCT03603275

Collaborator

American Thrombosis and Hemostasis Network (Other)

Enrollment

Locations

21.3

Actual Duration (Months)

0.1

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hemophilia A	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 Design

Study Type:

Observational

Actual Enrollment :

3 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Aug 6, 2018

Actual Primary Completion Date :

May 14, 2020

Actual Study Completion Date :

May 14, 2020

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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 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
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 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
Physicians reported discipline 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
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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

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

Sponsors and Collaborators

Bayer
American Thrombosis and Hemostasis Network

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

Responsible Party:

Bayer

ClinicalTrials.gov Identifier:

NCT03603275

Other Study ID Numbers:

19866

First Posted:

Jul 27, 2018

Last Update Posted:

Aug 25, 2022

Last Verified:

Aug 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hemophilia A

Study Results

No Results Posted as of Aug 25, 2022