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

Study Overview
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Brief Summary
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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

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

Conditions
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Hemophilia B

Intervention / Treatment
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* Other: Qualitative Interview - Participants/ Patients
* Other: Qualitative Interview - Investigators and Study Coordinators


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants/ Patients<br>Participants/ Patients from the AskBio009-101 Study | Other: Qualitative Interview - Participants/ Patients<br>* Qualitative interviews to understand the patient experience with the AskBio009-101 Study - Participants/ Patients<br>|
| Investigators and Study Coordinators<br>Investigators and Study Coordinators from the AskBio009-101 Study | Other: Qualitative Interview - Investigators and Study Coordinators<br>* Qualitative interviews to understand the patient experience with the AskBio009-101 Study - Investigators and Study Coordinators<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interview - AskBio009-101 Study - Participants/ Patients | Qualitative telephone interviews to understand the patient experience with the AskBio009-101 Study - Participant/ Patient Interview | Approximately 1 hour | 
| Interview - AskBio009-101 Study - Investigators and Study Coordinators | Qualitative telephone interviews to understand the patient experience with the AskBio009-101 Study - Investigators and Study Coordinators Interview | Approximately 1 hour |