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

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ClinicalTrials.gov Identifier: NCT03603275
Recruitment Status : Recruiting
First Posted : July 27, 2018
Last Update Posted : June 25, 2019
Sponsor:
Collaborator:
American Thrombosis and Hemostasis Network
Information provided by (Responsible Party):
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. 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
Hemophilia A Drug: Antihemophilic Factor (Kovaltry, BAY81-8973)

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 for another product to Kovaltry 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.


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Study Type : Observational
Estimated Enrollment : 128 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Assessing Hemophilia A Patient and Physician Reasons and Expectations for Switching Treatment to Kovaltry: A Nested Study Within an Existing Registry
Actual Study Start Date : August 6, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : April 30, 2022


Group/Cohort Intervention/treatment
Patient/caregiver of Kovaltry (BAY81-8973)
Patients who are switching factor replacement products to Kovaltry and patients who have switched factor replacement products to Kovaltry previously
Drug: Antihemophilic Factor (Kovaltry, BAY81-8973)
Kovaltry 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



Primary Outcome Measures :
  1. Patient reported reasons for switching FVIII replacement treatment to Kovaltry using a Bayer designed survey [ Time Frame: Up to 4 years ]
    Data from consenting patients will be collected by ATHN

  2. Patient expectations of switching FVIII replacement therapy to Kovaltry would affect lifestyle/quality of life using a Bayer designed survey [ Time Frame: Up to 4 years ]
    Data from consenting patients will be collected by ATHN

  3. Patient expectations when adjusting to the new product after switch using a Bayer designed survey [ Time Frame: Up to 4 years ]
    Data from consenting patients will be collected by ATHN

  4. Patient reported root of expectations using a Bayer designed survey [ Time Frame: Up to 4 years ]
    Data from consenting patients will be collected by ATHN

  5. Patient reported reasons that would deter them from switching FVIII replacement products using a Bayer designed survey [ Time Frame: Up to 4 years ]
    Data from consenting patients will be collected by ATHN

  6. Physicians reported discipline using a Bayer designed survey [ Time Frame: Up to 4 years ]
    Data from consenting patients will be collected by ATHN

  7. Physicians reported reasons for switching FVIII replacement treatment to Kovaltry using a Bayer designed survey [ Time Frame: Up to 4 years ]
    Data from consenting patients will be collected by ATHN

  8. Dosing Regimen (pre/post-switch) [ Time Frame: Up to 4 years ]
    Data from consenting patients will be collected by ATHN

  9. Physicians reported reason of newly selected dose/dosing interval using a Bayer designed survey [ Time Frame: Up to 4 years ]
    Data from consenting patients will be collected by ATHN

  10. Physicians reported rationale base for new dosing regimen selection using a Bayer designed survey [ Time Frame: Up to 4 years ]
    Data from consenting patients will be collected by ATHN

  11. Physicians reported communication about adjustment period when switching using a Bayer designed survey [ Time Frame: Up to 4 years ]
    Data from consenting patients will be collected by ATHN

  12. Physicians reported reasons that a provider would not encourage a patient to switch FVIII products using a Bayer designed survey [ Time Frame: Up to 4 years ]
    Data from consenting patients will be collected by ATHN



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Previously treated hemophilia A patients enrolled into existing registry who have switched FVIII replacement treatment to Kovaltry 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.
Criteria
Hemophilia A patients who have switched treatment to treatment with KOVALTRY within the past 50 weeks, who are enrolled the ATHN 2: Factor Switching Study, and who have consented to participate in the KOVALTRY specific module will be included in this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03603275


Contacts
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Contact: Bayer Clinical Trials Contact (+)1-888-84 22937 clinical-trials-contact@bayer.com

  Show 27 Study Locations
Sponsors and Collaborators
Bayer
American Thrombosis and Hemostasis Network

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03603275     History of Changes
Other Study ID Numbers: 19866
First Posted: July 27, 2018    Key Record Dates
Last Update Posted: June 25, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Factor VIII
Coagulants