Brief Title
Exit Interviews to Assess Impact of Infusion Frequency in Hemophilia A
Official Title
Exit Interviews to Assess Impact of Infusion Frequency in Hemophilia A
Brief Summary
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.
Study Type
Observational
Primary Outcome
Qualitative interviews (with patients) to determine patients' satisfaction
Condition
Hemophilia A
Intervention
BAY94-9027
Study Arms / Comparison Groups
Prophylaxis treatment of BAY94-9027_1
Description: 2 infusions per week during the extension study
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
30
Start Date
June 20, 2017
Completion Date
December 15, 2017
Primary Completion Date
November 26, 2017
Eligibility Criteria
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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT02971930
Organization ID
19144
Responsible Party
Sponsor
Study Sponsor
Bayer
Study Sponsor
, ,
Verification Date
January 2018