Exit Interviews to Assess Impact of Infusion Frequency in Hemophilia A

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-06-20

Study Completion Date

2017-12-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Hemophilia A

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Prophylaxis treatment of BAY94-9027_1

2 infusions per week during the extension study

BAY94-9027

Intervention Type BIOLOGICAL

Intravenous infusion of BAY94-9027

Prophylaxis treatment of BAY94-9027_2

infusion every 5 days during the extension study

BAY94-9027

Intervention Type BIOLOGICAL

Intravenous infusion of BAY94-9027

Prophylaxis treatment of BAY94-9027_3

every 7 days during the extension study

BAY94-9027

Intervention Type BIOLOGICAL

Intravenous infusion of BAY94-9027

Interventions

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BAY94-9027

Intravenous infusion of BAY94-9027

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No