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

NCT ID: NCT03603275

Last Updated: 2022-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

3 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-08-06

Study Completion Date

2020-05-14

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hemophilia A

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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

New FVIII products

Intervention Type DRUG

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

No interventions assigned to this group

Interventions

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New FVIII products

Kovaltry or Jivi prescribed by the treating Physician

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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.
Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American Thrombosis and Hemostasis Network

NETWORK

Sponsor Role collaborator

Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of California, San Diego

La Jolla, California, United States

Site Status

University of Colorado Denver Hemophilia and Thrombosis Center

Aurora, Colorado, United States

Site Status

Yale Hemophilia Treatment Center

New Haven, Connecticut, United States

Site Status

Children's National Medical Center

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

Site Status

Johns Hopkins All Children's Hospital

St. Petersburg, Florida, United States

Site Status

St. Josephs Hemophilia Treatment Center

Tampa, Florida, United States

Site Status

Emory / Children's Healthcare of Atlanta

Atlanta, Georgia, United States

Site Status

Bleeding and Clotting Disorders Institute

Peoria, Illinois, United States

Site Status

Indiana Hemophilia and Thrombosis Center IHTC

Indianapolis, Indiana, United States

Site Status

Louisiana Center for Bleeding and Clotting Disorders / Tulane

New Orleans, Louisiana, United States

Site Status

Maine Hemophilia and Thrombosis Center

Scarborough, Maine, United States

Site Status

The Johns Hopkins University Hemophilia Treatment Center

Baltimore, Maryland, United States

Site Status

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

Boston, Massachusetts, United States

Site Status

Univ of Michigan Hemophilia and Coagulation Disorders

Ann Arbor, Michigan, United States

Site Status

Michigan State University Center for Bleeding Disorders & Clotting Disorders

East Lansing, Michigan, United States

Site Status

Children's Mercy Hospital (Kansas City)

Kansas City, Missouri, United States

Site Status

Dartmouth-Hitchcock Comprehensive Hemophilia and Thrombosis Center

Lebanon, New Hampshire, United States

Site Status

Weill Cornell Medicine

New York, New York, United States

Site Status

Mary M. Gooley Hemophilia Center, Inc.

Rochester, New York, United States

Site Status

Oregon Health & Science University

Portland, Oregon, United States

Site Status

Children's Hospital of Philadelphia (CHOP)

Philadelphia, Pennsylvania, United States

Site Status

Penn Comprehensive Hemophilia and Thrombophilia Program / Hospital UPENN

Philadelphia, Pennsylvania, United States

Site Status

Hemophilia Center of Western Pennsylvania

Pittsburgh, Pennsylvania, United States

Site Status

St. Jude Children's Research Hospital

Memphis, Tennessee, United States

Site Status

UT Southwestern/Children's Health Dallas

Dallas, Texas, United States

Site Status

BloodWorks (Puget Sound)

Seattle, Washington, United States

Site Status

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

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

Related Links

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http://clinicaltrials.bayer.com/

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

Other Identifiers

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19866

Identifier Type: -

Identifier Source: org_study_id

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