Trial Condition(s):

Hemophilia A

Exit interviews to assess impact of infusion frequency in Hemophilia A

Bayer Identifier:

19144

ClinicalTrials.gov Identifier:

NCT02971930

EudraCT Number:

Not Available

Study Completed

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.

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.

Trial Summary

Enrollment Goal
30
Trial Dates
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Phase
N/A
Could I receive a placebo?
No
Products
Jivi (Damoctocog, BAY94-9027)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Cleveland

Cleveland, United States, 110605

Status
Completed
 

Trial Design