Exit Interviews to Assess Impact of Infusion Frequency in Hemophilia A



Status:Completed
Conditions:Anemia, Hematology
Therapuetic Areas:Hematology
Healthy:No
Age Range:18 - Any
Updated:2/3/2018
Start Date:June 20, 2017
End Date:December 15, 2017

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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.


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.
We found this trial at
1
site
Cleveland, Ohio 44108
?
mi
from
Cleveland, OH
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