Status:
COMPLETED
Evaluation of Patient and Physician Reported Reasons for Switching Factor VIII Replacement Therapies
Lead Sponsor:
Bayer
Conditions:
Hemophilia A
Eligibility:
All Genders
12+ years
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 14 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 13 2018
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT03405337
Start Date
February 14 2018
End Date
June 13 2018
Last Update
September 27 2018
Active Locations (1)
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1
Many Locations
Whippany, New Jersey, United States, 07981