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

Completed

• Conditions: Hemophilia A
• Interventions: Drug: FVIII products; Drug: Conventional FVIII replacement therapies

• Registration Number: NCT03405337
• Lead Sponsor: Bayer

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-01-15
• Study First Submitted QC: 2018-01-15
• Study First Posted: 2018-01-23
• Study Start: 2018-02-14
• Primary Completion: 2018-06-13
• Study Completion: 2018-06-13
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-26
• Last Update Posted: 2018-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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.

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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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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
FVIII products (retrospective)	FVIII products	Quantitative physician interview/ chart review study: Hemophilia A patients (N=100) who have switched from "conventional" FVIII replacement therapy to FVIII products with improved half-life.
FVIII products (retrospective)	Conventional FVIII replacement therapies	Quantitative physician interview/ chart review study: Hemophilia A patients (N=100) who have switched from "conventional" FVIII replacement therapy to FVIII products with improved half-life.
FVIII products (prospective)	FVIII products	Qualitative patient/caregiver study: Hemophilia A patients/caregivers (N=30) having initiated a FVIII products with improved half-life
FVIII products (prospective)	Conventional FVIII replacement therapies	Qualitative patient/caregiver study: Hemophilia A patients/caregivers (N=30) having initiated a FVIII products with improved half-life
Conventional FVIII replacement therapies	Conventional FVIII replacement therapies	Qualitative patient/caregiver study: Hemophilia A patients/caregivers (N=30) receiving "conventional" FVIII replacement therapy for at least 6 months who are considering switching to a FVIII product with improved half-life within the next 1 year

Primary Outcome Measures

Name	Time	Method
The clinical characteristics of patients who switch from conventional FVIII replacement therapy to FVIII products with improved half-life	Up to 4.5 months	A retrospective patient medical chart review
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	Up to 4.5 months	A retrospective patient medical chart review
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	Up to 6 days	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.
The reasons of patients/caregivers "switch" from conventional FVIII replacement therapy to FVIII products with improved half-life	Up to 6 days	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.
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	Up to 4.5 months	A retrospective patient medical chart review
The reasons for switching from conventional FVIII replacement therapy to FVIII products with improved half-life, from the physician perspective	Up to 4.5 months	A retrospective patient medical chart review

Trial Locations

Locations (1)

Many Locations; 🇺🇸 Whippany, New Jersey, United States