Hemophilia APARkERNCT03405337
Evaluation of Patient and Physician Reported Reasons for Switching Factor VIII Replacement Therapies
An observational study of Hemophilia A, run by Bayer at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Hemophilia A
- What is being tested?
- FVIII products and Conventional FVIII replacement therapies
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Feb 2018to 13 Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Show all 15Show fewer
- 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
- 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.
Who cannot join
- 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.
- Unwilling to comply with the study protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Hemophilia A
- Being tested
- FVIII products, Conventional FVIII replacement therapies
- Medical subject headings
- Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FVIII productsDrug
Adynovate, Eloctate, Afstyla, Kovaltry
Conventional FVIII replacement therapiesDrug
Advate, Kogenate FS, Helixate, Novoeight, Nuwiq, Recombinate, Xyntha
| Study group | Role | What they receive |
|---|---|---|
| FVIII products (prospective) | Qualitative patient/caregiver study:
Hemophilia A patients/caregivers (N=30) having initiated a FVIII products with improved half-life Receives: Drug: FVIII products; Drug: 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 Receives: Drug: Conventional FVIII replacement therapies | |
| 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. Receives: Drug: FVIII products; Drug: Conventional FVIII replacement therapies |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Up to 6 days
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
Measured: 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
A retrospective patient medical chart review
Measured: 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
A retrospective patient medical chart review
Measured: 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
A retrospective patient medical chart review
Measured: Up to 4.5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start14 Feb 2018
- Primary completion13 Jun 2018
- Study completion13 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemophilia AStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03405337
- Sponsor's protocol ID
- 19529
- Acronym
- PARkER
- Status last verified
- Sep 2018
- First submitted
- 15 Jan 2018
- Last updated
- 27 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Patient and Physician Reported Reasons for Switching FVIII Replacement Therapies
- ClinicalTrials.gov ID
- NCT03405337
- Acronym / sponsor ID
- PARkER / 19529
- Conditions
- Hemophilia A
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 14 Feb 2018 (actual)
- Primary completion
- 13 Jun 2018 (actual)
- Study completion
- 13 Jun 2018 (actual)
- First posted
- 23 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| FVIII products (prospective) | – | Drug: FVIII products, Drug: Conventional FVIII replacement therapiesQualitative patient/caregiver study: Hemophilia A patients/caregivers (N=30) having initiated a FVIII products with improved half-life |
| Conventional FVIII replacement therapies | – | Drug: Conventional FVIII replacement therapiesQualitative 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 |
| FVIII products (retrospective) | – | Drug: FVIII products, Drug: Conventional FVIII replacement therapiesQuantitative 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. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FVIII productsAdynovate, Eloctate, Afstyla, Kovaltry | Drug | FVIII products (prospective), FVIII products (retrospective) |
| Conventional FVIII replacement therapiesAdvate, Kogenate FS, Helixate, Novoeight, Nuwiq, Recombinate, Xyntha | Drug | Conventional FVIII replacement therapies, FVIII products (prospective), FVIII products (retrospective) |
Primary outcome
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.
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.
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemophilia A, run by Bayer at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The reasons of patients/caregivers "switch" from conventional FVIII replacement therapy to FVIII products with improved half-life (time frame: Up to 6 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2018.