Exit Interviews to Assess Impact of Infusion Frequency in Hemophilia A

NCT02971930 | Completed

• 1 other identifier: 19144
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemophilia A

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (3)

Prophylaxis treatment of BAY94-9027_1

2 infusions per week during the extension study

Biological: BAY94-9027

Prophylaxis treatment of BAY94-9027_2

infusion every 5 days during the extension study

Biological: BAY94-9027

Prophylaxis treatment of BAY94-9027_3

every 7 days during the extension study

Biological: BAY94-9027

Interventions

BAY94-9027 BIOLOGICAL

Intravenous infusion of BAY94-9027

Prophylaxis treatment of BAY94-9027_1; Prophylaxis treatment of BAY94-9027_2; Prophylaxis treatment of BAY94-9027_3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of patients aged 18+ years who are participating in the BAY94-9027 extension studies or who are within 3 months of exiting the study.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Cleveland

Cleveland, Ohio, 110605, United States

Location

MeSH Terms

Conditions

Hemophilia A

Interventions

Factor VIII

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Protein Precursors; Biological Factors

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2016
• First Posted: November 23, 2016
• Study Start: June 20, 2017
• Primary Completion: November 26, 2017
• Study Completion: December 15, 2017
• Last Updated: February 1, 2018

Record last verified: 2018-01

Locations

US (1)