Non-Interventional Study to Capture the Patient Experience on Gene Therapy for Hemophilia Within the AskBio009-101 Study Through Patient and Investigator Interviews
Study Details
Study Description
Brief Summary
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
Condition or Disease | Intervention/Treatment | Phase |
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Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Participants/ Patients Participants/ Patients from the AskBio009-101 Study |
Other: Qualitative Interview - Participants/ Patients
Qualitative interviews to understand the patient experience with the AskBio009-101 Study - Participants/ Patients
|
Investigators and Study Coordinators Investigators and Study Coordinators from the AskBio009-101 Study |
Other: Qualitative Interview - Investigators and Study Coordinators
Qualitative interviews to understand the patient experience with the AskBio009-101 Study - Investigators and Study Coordinators
|
Outcome Measures
Primary Outcome Measures
- Interview - AskBio009-101 Study - Participants/ Patients [Approximately 1 hour]
Qualitative telephone interviews to understand the patient experience with the AskBio009-101 Study - Participant/ Patient Interview
- Interview - AskBio009-101 Study - Investigators and Study Coordinators [Approximately 1 hour]
Qualitative telephone interviews to understand the patient experience with the AskBio009-101 Study - Investigators and Study Coordinators Interview
Eligibility Criteria
Criteria
Inclusion criteria for patients:
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Were screened and consented for the AskBio009-101study at any point in time
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Are able to speak and understand English
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Are between ages of 18 and 75
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Are physically able to participate in a one-hour phone interview
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Consented into this study independently of the AskBio009-101 study
Exclusion criteria for patients:
- N/A
Inclusion criteria for investigators and coordinators:
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Worked at a site as an investigator or study coordinator that consented a patient into the
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AskBio009-101 trial at any point in time, including those that no longer work at a AskBio009-101 site
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Are able to speak and understand English
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Are between ages of 18 and 75
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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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | QuintilesIMS | Cambridge | Massachusetts | United States | 02139 |
Sponsors and Collaborators
- Baxalta now part of Shire
Investigators
- Study Director: Study Director, Takeda
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 001601