Exit Interviews to Assess Impact of Inf… | Clinical Trial

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cleveland

Cleveland, Ohio, 110605, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BAY94-9027

Biological

Intravenous infusion of BAY94-9027

Primary outcomes

Qualitative interviews (with patients) to determine patients' satisfaction

Time frame: up to 4 months

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
Qualitative interviews (with patients) to determine patients' quality of life

Time frame: up to 4 months

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;
Qualitative interviews (with treating physicians) to determine patients' satisfaction

Time frame: up to 4 months

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
Qualitative interviews (with treating physicians) to determine patients' quality of life

Time frame: up to 4 months

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;

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Important dates

Study start: 2017
Primary completion: 2017
Study completion: 2017
First posted: Nov 23, 2016
Registry last updated: Feb 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed