Exit Interviews to Assess Impact of Infusion Frequency in Hemophilia A

Hemophilia A Clinical Trial

Official title:

Exit Interviews to Assess Impact of Infusion Frequency in Hemophilia A

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02971930
• Other study ID #: 19144
• Status: Completed
• Phase: N/A
• First received: October 27, 2016
• Last updated: January 30, 2018
• Start date: June 20, 2017
• Est. completion date: December 15, 2017

Study information

• Verified date: January 2018
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 15, 2017
• Est. primary completion date: November 26, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hemophilia A

Intervention

Biological:
• BAY94-9027
Intravenous infusion of BAY94-9027

Locations

Country	Name	City	State
United States	Cleveland	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Qualitative interviews (with patients) to determine patients' satisfaction	To conduct qualitative interviews with patients with Hemophilia A who have participated in the BAY94-9027 extension studies to evaluate patient experiences of and perspectives regarding their current treatment and the extent to which the frequency of FVIII infusions (compared to previous treatments) influences satisfaction	up to 4 months
Primary	Qualitative interviews (with patients) to determine patients' quality of life	To conduct qualitative interviews with patients with Hemophilia A who have participated in the BAY94-9027 extension studies to evaluate patient experiences of and perspectives regarding their current treatment and the extent to which the frequency of FVIII infusions (compared to previous treatments) influences quality of life;	up to 4 months
Primary	Qualitative interviews (with treating physicians) to determine patients' satisfaction	To conduct qualitative interview with clinicians who treat patients with Hemophilia A who have participated in the BAY94-9027 extension studies to evaluate the clinician perspective of patient experiences of and perspectives regarding their current treatment and the extent to which the frequency of FVIII infusions (compared to previous treatments) influences their patients' satisfaction	up to 4 months
Primary	Qualitative interviews (with treating physicians) to determine patients' quality of life	To conduct qualitative interview with clinicians who treat patients with Hemophilia A who have participated in the BAY94-9027 extension studies to evaluate the clinician perspective of patient experiences of and perspectives regarding their current treatment and the extent to which the frequency of FVIII infusions (compared to previous treatments) influences their patients' quality of life;	up to 4 months