Exit Interviews to Assess Impact of Infusion Frequency in Hemophilia A

Exit Interviews to Assess Impact of Infusion Frequency in Hemophilia A

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.

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.