Evaluation of Patient and Physician Reported Reasons for Switching Factor VIII Replacement Therapies

Hemophilia A Clinical Trial

— PARkER  

Official title:

Evaluation of Patient and Physician Reported Reasons for Switching FVIII Replacement Therapies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03405337
• Other study ID #: 19529
• Status: Completed
• Start date: February 14, 2018
• Est. completion date: June 13, 2018

Study information

• Verified date: September 2018
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: June 13, 2018
• Est. primary completion date: June 13, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemophilia A

Intervention

Drug:
• FVIII products
Adynovate, Eloctate, Afstyla, Kovaltry
• Conventional FVIII replacement therapies
Advate, Kogenate FS, Helixate, Novoeight, Nuwiq, Recombinate, Xyntha

Locations

Country	Name	City	State
United States	Many Locations	Whippany	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 6 days
Primary	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.	Up to 6 days
Primary	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	Up to 4.5 months
Primary	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	Up to 4.5 months
Primary	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	Up to 4.5 months
Primary	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	Up to 4.5 months