Brief Title
Evaluation of Patient and Physician Reported Reasons for Switching Factor VIII Replacement Therapies
Official Title
Evaluation of Patient and Physician Reported Reasons for Switching FVIII Replacement Therapies
Brief Summary
This US study will assess hemophilia A patient characteristics, health history and reasons for switching or not switching from both patient/caregiver and physician perspectives. For this purpose, this research study will include hemophilia A: 1) patients who have switched from conventional therapy to new FVIII products with an improved PK profile. 2) patients who remain on conventional therapy (who have never switched) but have considered switching, including those patients who switched from conventional therapy to new FVIII products with improved pharmacokinetics and then subsequently "switched back" to conventional replacement therapy. 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.
Study Type
Observational
Primary Outcome
The reasons of patients/caregivers "switch" from conventional FVIII replacement therapy to FVIII products with improved half-life
Condition
Hemophilia A
Intervention
FVIII products
Study Arms / Comparison Groups
FVIII products (prospective)
Description: Qualitative patient/caregiver study: Hemophilia A patients/caregivers (N=30) having initiated a FVIII products with improved half-life
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
160
Start Date
February 14, 2018
Completion Date
June 13, 2018
Primary Completion Date
June 13, 2018
Eligibility Criteria
Inclusion Criteria: Inclusion criteria for patients/caregivers in the Patient/Caregiver Study: - Patients with hemophilia A (≥ 18 years of age) or caregivers of children with hemophilia A (≥12-<18 years of age) - Group 1: Hemophilia A patients/caregivers who have switched to FVIII products with improved half-life for the treatment of hemophilia A during the eligibility period. These patients can also include those who have switched back from FVIII products with improved half-life to conventional FVIII replacement therapy within the Data Collection Period - Group 2: Hemophilia A patients/caregivers who are considering switching to FVIII products with improved half-life within 12 months of the Start of the Documentation period and have been prescribed prophylaxis regimen of at least 2x/week - Able to understand, read, write and speak English - Provide electronic informed consent - Able to access the Internet for at least 20 minutes per day during the Data Collection Period Inclusion criteria for physicians: - At least 60% of time spent in direct patient care - Board-certified or eligible with a Specialty in Hematology or Hematology-Oncology - Physicians with a specialty in Hematology-Oncology must have at least 10% of their practice dedicated to treatment of hemophilia - A minimum of 2 years' experience treating hemophilia A patients Inclusion criteria for patients in the physician chart study: - Hemophilia A patients age 12 year and over - Prior treatment with one of the following FVIII replacement products: Adynovate, Afstyla, Eloctate, or Kovaltry - Patients that have 12 months of medical chart data available; 6 months on conventional therapy and 6 months after switching to FVIII products with improved half-life. Exclusion Criteria: Exclusion criteria for patients/caregivers in the Patient/Caregiver Study: - Hemophilia A patient initiated FVIII products with improved half-life for the treatment at time of diagnosis with hemophilia A. Exclusion criteria for physicians: - Unwilling to comply with the study protocol
Gender
All
Ages
12 Years - N/A
Accepts Healthy Volunteers
No
Contacts
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Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT03405337
Organization ID
19529
Responsible Party
Sponsor
Study Sponsor
Bayer
Study Sponsor
, ,
Verification Date
September 2018