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

NCT03603275 | Terminated

• 1 other identifier: 19866
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 27

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.

Conditions

Hemophilia A

Outcome Measures

Primary Outcomes (12)

• 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

Study Arms (2)

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

Physician Group

Physicians participating in the study are associated with US hemophilia treatment centers that are affiliated with the ATHN hemophilia treatment center network

Interventions

New FVIII products DRUG

Kovaltry or Jivi prescribed by the treating Physician

Patient/caregiver of Kovaltry or Jivi

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Bayer: lead
• American Thrombosis and Hemostasis Network: collaborator

Study Sites (27)

University of California, San Diego

La Jolla, California, 92093, United States

Location

University of Colorado Denver Hemophilia and Thrombosis Center

Aurora, Colorado, 80045, United States

Location

Yale Hemophilia Treatment Center

New Haven, Connecticut, 06510, United States

Location

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

Johns Hopkins All Children's Hospital

St. Petersburg, Florida, 33701, United States

Location

St. Josephs Hemophilia Treatment Center

Tampa, Florida, 33607, United States

Location

Emory / Children's Healthcare of Atlanta

Atlanta, Georgia, 30322, United States

Location

Bleeding and Clotting Disorders Institute

Peoria, Illinois, 61615, United States

Location

Indiana Hemophilia and Thrombosis Center IHTC

Indianapolis, Indiana, 46260, United States

Location

Louisiana Center for Bleeding and Clotting Disorders / Tulane

New Orleans, Louisiana, 70112, United States

Location

Maine Hemophilia and Thrombosis Center

Scarborough, Maine, 04074, United States

Location

The Johns Hopkins University Hemophilia Treatment Center

Baltimore, Maryland, 21205, United States

Location

Boston Hemophilia Center at Children's Hospital of Boston/Brigham Women's

Boston, Massachusetts, 02115, United States

Location

Univ of Michigan Hemophilia and Coagulation Disorders

Ann Arbor, Michigan, 48109, United States

Location

Michigan State University Center for Bleeding Disorders & Clotting Disorders

East Lansing, Michigan, 48824, United States

Location

Children's Mercy Hospital (Kansas City)

Kansas City, Missouri, 64108, United States

Location

Dartmouth-Hitchcock Comprehensive Hemophilia and Thrombosis Center

Lebanon, New Hampshire, 03756, United States

Location

Weill Cornell Medicine

New York, New York, 10065, United States

Location

Mary M. Gooley Hemophilia Center, Inc.

Rochester, New York, 14621, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Children's Hospital of Philadelphia (CHOP)

Philadelphia, Pennsylvania, 01914, United States

Location

Penn Comprehensive Hemophilia and Thrombophilia Program / Hospital UPENN

Philadelphia, Pennsylvania, 19104, United States

Location

Hemophilia Center of Western Pennsylvania

Pittsburgh, Pennsylvania, 15213, United States

Location

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

UT Southwestern/Children's Health Dallas

Dallas, Texas, 75390, United States

Location

BloodWorks (Puget Sound)

Seattle, Washington, 98104, United States

Location

Blood Center of Wisconsin, Inc. /Childrens Hosp of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related 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

MeSH Terms

Conditions

Hemophilia A

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2018
• First Posted: July 27, 2018
• Study Start: August 6, 2018
• Primary Completion: May 14, 2020
• Study Completion: May 14, 2020
• Last Updated: August 25, 2022

Record last verified: 2022-08

Locations

US (27)