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

September 26, 2018 updated by: Bayer

Evaluation of Patient and Physician Reported Reasons for Switching FVIII 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
160

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Whippany, New Jersey, United States, 07981
        • Many Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Study Population for the Patient/Caregiver Study:

Hemophilia A patients/caregivers will be recruited via opt-in patient panels and/or research databases.

Patients with hemophilia A (≥ 18 years of age) or caregivers of children with hemophilia A (≥12-<18 years of age)

Study Population for the Physician Chart Study:

The study population for the physician chart review study will be patients, who initiated FVIII products with improved half-life for the treatment of hemophilia A during the eligibility period. In order to obtain a broad patient population that is representative of real world prescribing; all eligible patients will be included in the study irrespective of the FVIII product with improved half-life received.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
FVIII products (prospective)

Qualitative patient/caregiver study:

Hemophilia A patients/caregivers (N=30) having initiated a FVIII products with improved half-life
Drug: FVIII products
Adynovate, Eloctate, Afstyla, Kovaltry
Drug: Conventional FVIII replacement therapies
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
Drug: Conventional FVIII replacement therapies
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.
Drug: FVIII products
Adynovate, Eloctate, Afstyla, Kovaltry
Drug: Conventional FVIII replacement therapies
Advate, Kogenate FS, Helixate, Novoeight, Nuwiq, Recombinate, Xyntha

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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
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.
Up to 6 days
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
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
Time Frame: Up to 4.5 months
A retrospective patient medical chart review
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
Time Frame: Up to 4.5 months
A retrospective patient medical chart review
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
Time Frame: Up to 4.5 months
A retrospective patient medical chart review
Up to 4.5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 14, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 13, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 13, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 15, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 15, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 23, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 27, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 26, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 19529

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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