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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-02-14

Study Completion Date

2018-06-13

Brief Summary

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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.

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Detailed Description

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Conditions

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Hemophilia A

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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FVIII products (prospective)

Qualitative patient/caregiver study:

Hemophilia A patients/caregivers (N=30) having initiated a FVIII products with improved half-life

FVIII products

Intervention Type DRUG

Adynovate, Eloctate, Afstyla, Kovaltry

Conventional FVIII replacement therapies

Intervention Type DRUG

Advate, Kogenate FS, Helixate, Novoeight, Nuwiq, Recombinate, Xyntha

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

Conventional FVIII replacement therapies

Intervention Type DRUG

Advate, Kogenate FS, Helixate, Novoeight, Nuwiq, Recombinate, Xyntha

FVIII products (retrospective)

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

Intervention Type DRUG

Adynovate, Eloctate, Afstyla, Kovaltry

Conventional FVIII replacement therapies

Intervention Type DRUG

Advate, Kogenate FS, Helixate, Novoeight, Nuwiq, Recombinate, Xyntha

Interventions

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FVIII products

Adynovate, Eloctate, Afstyla, Kovaltry

Intervention Type DRUG

Conventional FVIII replacement therapies

Advate, Kogenate FS, Helixate, Novoeight, Nuwiq, Recombinate, Xyntha

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

* 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

* 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

\- Hemophilia A patient initiated FVIII products with improved half-life for the treatment at time of diagnosis with hemophilia A.

\- Unwilling to comply with the study protocol

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No