check_circleStudy Completed

Hemophilia A

Bayer Identifier:

19529

ClinicalTrials.gov Identifier:

NCT03405337

EudraCT Number:

Not Available

EU CT Number:

Not Available
Evaluation of Patient and Physician Reported Reasons for Switching factor VIII Replacement Therapies

Trial purpose

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.

Key Participants Requirements

Sex

All

Age

12 Years
  • 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 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

Trial summary

Enrollment Goal
160
Trial Dates
February 2018 - June 2018
Phase
N/A
Could I Receive a placebo
No
Products
Kovaltry (Antihemophilic Factor [Recombinant], BAY81-8973)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many LocationsWhippany, 07981, United States

Primary Outcome

  • The reasons of patients/caregivers “switch” from conventional FVIII replacement therapy to FVIII products with improved half-life
    These patients/caregivers will participate in an asynchronous online discussion forum consisting of predetermined open ended and close ended questions for a series of 6 consecutive days completing approximately 20 minutes’ worth of questions per day.
    date_rangeTime Frame:
    Up to 6 days
  • The obstacles of switching among hemophilia A patients who did not switch from conventional therapy to FVIII products with improved half-life but who are open to switching
    These patients/caregivers will participate in an asynchronous online discussion forum consisting of predetermined open ended and close ended questions for a series of 6 consecutive days completing approximately 20 minutes’ worth of questions per day.
    date_rangeTime Frame:
    Up to 6 days
  • The clinical characteristics of patients who switch from conventional FVIII replacement therapy to FVIII products with improved half-life
    A retrospective patient medical chart review
    date_rangeTime Frame:
    Up to 4.5 months
  • The changes of treatment characteristics from 6 months prior to switching compared to 6 months after switching from conventional FVIII replacement therapy to FVIII products with improved half-life
    A retrospective patient medical chart review
    date_rangeTime Frame:
    Up to 4.5 months
  • The changes of bleeding related outcomes from 6 months prior to switching compared to 6 months after switching from conventional FVIII replacement therapy to FVIII products with improved half-life
    A retrospective patient medical chart review
    date_rangeTime Frame:
    Up to 4.5 months
  • The reasons for switching from conventional FVIII replacement therapy to FVIII products with improved half-life, from the physician perspective
    A retrospective patient medical chart review
    date_rangeTime Frame:
    Up to 4.5 months

Trial design

Evaluation of Patient and Physician Reported Reasons for Switching FVIII Replacement Therapies
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A