check_circleStudy Completed

Hemophilia A

Exit interviews to assess impact of infusion frequency in Hemophilia A

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - 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.


  • - 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.

Trial summary

Enrollment Goal
30
Trial Dates
June 2017 - December 2017
Phase
N/A
Could I Receive a placebo
No
Products
Jivi (Damoctocog, BAY94-9027)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
ClevelandCleveland, 110605, United States

Primary Outcome

  • 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
    date_rangeTime Frame:
    up to 4 months
    enhanced_encryption
    Safety Issue:
    No
  • 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;
    date_rangeTime Frame:
    up to 4 months
    enhanced_encryption
    Safety Issue:
    No
  • 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
    date_rangeTime Frame:
    up to 4 months
    enhanced_encryption
    Safety Issue:
    No
  • 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;
    date_rangeTime Frame:
    up to 4 months
    enhanced_encryption
    Safety Issue:
    No

Trial design

Exit interviews to assess impact of infusion frequency in Hemophilia A
Trial Type
Observational
Intervention Type
Biological/Vaccine
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A