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NCT Number: NCT03405337

Evaluation of Patient and Physician Reported Reasons for Switching Factor VIII 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.

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Key information

Conditions

Hemophilia A Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations

Whippany, New Jersey, 07981, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FVIII products

Drug

Adynovate, Eloctate, Afstyla, Kovaltry

Conventional FVIII replacement therapies

Drug

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

Primary outcomes

  1. The reasons of patients/caregivers "switch" from conventional FVIII replacement therapy to FVIII products with improved half-life

    Time frame: 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.

  2. 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

    Time frame: 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.

  3. The clinical characteristics of patients who switch from conventional FVIII replacement therapy to FVIII products with improved half-life

    Time frame: Up to 4.5 months

    A retrospective patient medical chart review

  4. 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

    Time frame: Up to 4.5 months

    A retrospective patient medical chart review

  5. 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

    Time frame: Up to 4.5 months

    A retrospective patient medical chart review

  6. The reasons for switching from conventional FVIII replacement therapy to FVIII products with improved half-life, from the physician perspective

    Time frame: Up to 4.5 months

    A retrospective patient medical chart review

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Acronym: PARkER

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jan 23, 2018
Registry last updated
Sep 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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