Non-Interventional Study to Capture the Patient Experience on Gene Therapy for Hemophilia Within the AskBio009-101 Study Through Patient and Investigator Interviews

Baxalta

Status: Completed

Conditions: Hemophilia B

Treatments: Other: Qualitative Interview - Participants/ Patients; Other: Qualitative Interview - Investigators and Study Coordinators

Study type: Observational

Funder types: Industry

Identifiers

NCT03054389

001601

Details and patient eligibility

About

The purpose of this study is to seek to understand the patient's perspective around deciding to participate in a clinical trial for a Hemophilia therapy

Enrollment: 27 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria for patients:

• Were screened and consented for the AskBio009-101study at any point in time
• Are able to speak and understand English
• Are between ages of 18 and 75
• Are physically able to participate in a one-hour phone interview
• Consented into this study independently of the AskBio009-101 study

Exclusion criteria for patients:

• N/A

Inclusion criteria for investigators and coordinators:

• Worked at a site as an investigator or study coordinator that consented a patient into the
• AskBio009-101 trial at any point in time, including those that no longer work at a AskBio009-101 site
• Are able to speak and understand English
• Are between ages of 18 and 75
• Are physically able to participate in a one-hour phone interview

Exclusion criteria for investigators and coordinators:

• Not directly involved in the consent process at the gene therapy site

Trial design

27 participants in 2 patient groups

Participants/ Patients

Description:

Participants/ Patients from the AskBio009-101 Study

Treatment:

Other: Qualitative Interview - Participants/ Patients

Investigators and Study Coordinators

Description:

Investigators and Study Coordinators from the AskBio009-101 Study

Treatment:

Other: Qualitative Interview - Investigators and Study Coordinators