Evaluation of Patient and Physician Reported Reasons for Switching Factor VIII Replacement Therapies
| Status: | Completed |
|---|---|
| Conditions: | Anemia, Hematology |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | 12 - Any |
| Updated: | 9/29/2018 |
| Start Date: | February 14, 2018 |
| End Date: | June 13, 2018 |
Evaluation of Patient and Physician Reported Reasons for Switching FVIII Replacement Therapies
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.
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.
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
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