An observational study in Hemophilia A, sponsored by Bayer. Completed at 1 site in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2018-09-27.
Sponsored by Bayer · Observational
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 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.
Inclusion Criteria:
Inclusion criteria for patients/caregivers in the Patient/Caregiver Study:
Inclusion criteria for physicians:
Inclusion criteria for patients in the physician chart study:
Exclusion Criteria:
Exclusion criteria for patients/caregivers in the Patient/Caregiver Study:
Exclusion criteria for physicians:
Qualitative patient/caregiver study: Hemophilia A patients/caregivers (N=30) having initiated a FVIII products with improved half-life
Drug: FVIII products · Drug: 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
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 · Drug: Conventional FVIII replacement therapies
Adynovate, Eloctate, Afstyla, Kovaltry
Advate, Kogenate FS, Helixate, Novoeight, Nuwiq, Recombinate, Xyntha
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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Up to 4.5 months
This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.
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