stop_circleTerminated/Withdrawn

Hemophilia A

Bayer Identifier:

19866

ClinicalTrials.gov Identifier:

NCT03603275

EudraCT Number:

Not Available

EU CT Number:

Not Available
Assessing Physician and Hemophilia A Patient Reasons and Expectations for Switching Treatment to Kovaltry & Jivi: A Nested Study within an Existing Registry

Trial purpose

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.

Key Participants Requirements

Sex

All

Age

2 Years
  • 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.

Trial summary

Enrollment Goal
3
Trial Dates
August 2018 - May 2020
Phase
Phase 4
Could I Receive a placebo
No
Products
Kovaltry (Antihemophilic Factor [Recombinant], BAY81-8973)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Yale Hemophilia Treatment CenterNew Haven, 06510, United States
Completed
Maine Hemophilia and Thrombosis CenterScarborough, 04074, United States
Completed
Dartmouth-Hitchcock Comprehensive Hemophilia and Thrombosis CenterLebanon, 03756, United States
Completed
Boston Hemophilia Center at Children's Hospital of Boston/Brigham Women'sBoston, 02115, United States
Completed
Children's Hospital of Philadelphia (CHOP)Philadelphia, 01914, United States
Completed
Weill Cornell MedicineNew York, 10065, United States
Completed
Mary M. Gooley Hemophilia Center, Inc.Rochester, 14621, United States
Completed
Children's National Medical CenterWashington, 20010, United States
Completed
Hemophilia Center of Western PennsylvaniaPittsburgh, 15213, United States
Completed
The Johns Hopkins University Hemophilia Treatment CenterBaltimore, 21205, United States
Completed
Penn Comprehensive Hemophilia and Thrombophilia Program / Hospital UPENNPhiladelphia, 19104, United States
Completed
St. Jude Children's Research HospitalMemphis, 38105, United States
Completed
St. Josephs Hemophilia Treatment CenterTampa, 33607, United States
Completed
Emory / Children's Healthcare of AtlantaAtlanta, 30322, United States
Completed
Johns Hopkins All Children's HospitalSt. Petersburgh, 33701, United States
Completed
Indiana Hemophilia and Thrombosis Center IHTCIndianapolis, 46260, United States
Completed
Michigan State University Center for Bleeding Disorders & Clotting DisordersEast Lansing, 48824, United States
Completed
Univ of Michigan Hemophilia and Coagulation DisordersAnn Arbor, 48109, United States
Completed
Bleeding and Clotting Disorders InstitutePeoria, 61615, United States
Completed
Blood Center of Wisconsin, Inc. /Childrens Hosp of WisconsinMilwaukee, 53226, United States
Completed
Louisiana Center for Bleeding and Clotting Disorders / TulaneNew Orleans, 70112, United States
Completed
UT Southwestern/Children's Health DallasDallas, 75390, United States
Completed
Children's Mercy Hospital (Kansas City)Kansas City, 64108, United States
Completed
University of Colorado Denver Hemophilia and Thrombosis CenterAurora, 80045, United States
Completed
University of California, San DiegoLa Jolla, 92093, United States
Completed
BloodWorks (Puget Sound)Seattle, 98104, United States
Completed
Oregon Health & Science UniversityPortland, 97239, United States

Primary Outcome

  • 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
    date_rangeTime Frame:
    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
    date_rangeTime Frame:
    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
    date_rangeTime Frame:
    Up to 4 years
  • Patient reported root of expectations using a Bayer designed survey
    Data from consenting patients will be collected by ATHN
    date_rangeTime Frame:
    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
    date_rangeTime Frame:
    Up to 4 years
  • Physicians reported discipline using a Bayer designed survey
    Data from consenting patients will be collected by ATHN
    date_rangeTime Frame:
    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
    date_rangeTime Frame:
    Up to 4 years
  • Dosing Regimen (pre/post-switch)
    Data from consenting patients will be collected by ATHN
    date_rangeTime Frame:
    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
    date_rangeTime Frame:
    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
    date_rangeTime Frame:
    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
    date_rangeTime Frame:
    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
    date_rangeTime Frame:
    Up to 4 years

Trial design

Assessing Hemophilia A Patient and Physician Reasons and Expectations for Switching Treatment to Kovaltry & Jivi: A Nested Study within an Existing Registry
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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