Exit Interviews to Assess Impact of Infusion Frequency in Hemophilia A

Study Overview
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Brief Summary
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This study is to generate qualitative data to evaluate the impact of frequency of FVIII infusions on patients' satisfaction with treatment and their quality of life.

Official Title
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Exit Interviews to Assess Impact of Infusion Frequency in Hemophilia A

Conditions
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Hemophilia A

Intervention / Treatment
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* Biological: BAY94-9027


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is enrolled in the BAY94-9027 extension studies or is within 3 months of having completed participation in the BAY94-9027 extension studies; Patient allocated to Arm 2, Arm 3 or Arm 4 of BAY94-9027 extension studies. Arm 2 Prophylaxis treatment of BAY94-9027; 2 infusions per week during the extension study Arm 3 Prophylaxis treatment of BAY94-9027; infusion every 5 days during the extension study Arm 4 Prophylaxis treatment of BAY94-9027; every 7 days during the extension study Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study; Patient must be willing and able to participate in a telephone interview lasting up to 30 minutes; Patient must have sufficient cognitive and linguistic capacities to allow them to actively participate in an interview lasting 30 minutes. Exclusion Criteria: Patient is part of Arm 1: On-demand treatment of BAY94-9027 at individual dose and number of infusions based upon location and severity of bleeds; Patient is unlikely to comply with the study protocol (e.g. uncooperative attitude) or unlikely to complete the study for any reason in the opinion of the recruiter; Patient has great difficulty hearing or reading; Patient has any significant comorbid condition (including uncontrolled psychiatric conditions) that might limit or interfere with their ability to talk about their Hemophilia A and participate in the study; Patient has severe neurological or cognitive deficits that might affect their ability to participate in an interview.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Prophylaxis treatment of BAY94-9027_1<br>2 infusions per week during the extension study | Biological: BAY94-9027<br>* Intravenous infusion of BAY94-9027<br>|
| Prophylaxis treatment of BAY94-9027_2<br>infusion every 5 days during the extension study | Biological: BAY94-9027<br>* Intravenous infusion of BAY94-9027<br>|
| Prophylaxis treatment of BAY94-9027_3<br>every 7 days during the extension study | Biological: BAY94-9027<br>* Intravenous infusion of BAY94-9027<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Qualitative interviews (with patients) to determine patients' satisfaction | To conduct qualitative interviews with patients with Hemophilia A who have participated in the BAY94-9027 extension studies to evaluate patient experiences of and perspectives regarding their current treatment and the extent to which the frequency of FVIII infusions (compared to previous treatments) influences satisfaction | up to 4 months | 
| Qualitative interviews (with patients) to determine patients' quality of life | To conduct qualitative interviews with patients with Hemophilia A who have participated in the BAY94-9027 extension studies to evaluate patient experiences of and perspectives regarding their current treatment and the extent to which the frequency of FVIII infusions (compared to previous treatments) influences quality of life; | up to 4 months | 
| Qualitative interviews (with treating physicians) to determine patients' satisfaction | To conduct qualitative interview with clinicians who treat patients with Hemophilia A who have participated in the BAY94-9027 extension studies to evaluate the clinician perspective of patient experiences of and perspectives regarding their current treatment and the extent to which the frequency of FVIII infusions (compared to previous treatments) influences their patients' satisfaction | up to 4 months | 
| Qualitative interviews (with treating physicians) to determine patients' quality of life | To conduct qualitative interview with clinicians who treat patients with Hemophilia A who have participated in the BAY94-9027 extension studies to evaluate the clinician perspective of patient experiences of and perspectives regarding their current treatment and the extent to which the frequency of FVIII infusions (compared to previous treatments) influences their patients' quality of life; | up to 4 months |