Exit Interviews to Assess Impact of Infusion Frequency in Hemophilia A

Bayer

Status

Completed

Conditions

Hemophilia A

Treatments

Biological: BAY94-9027

Study type

Observational

Funder types

Industry

Identifiers

NCT02971930

19144

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.