Brief Title
Non-Interventional Study to Capture the Patient Experience on Gene Therapy for Hemophilia Within the AskBio009-101 Study Through Patient and Investigator Interviews
Official Title
Non-Interventional Study to Capture the Patient Experience on Gene Therapy for Hemophilia Within the AskBio009-101 Study Through Patient and Investigator Interviews
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
Study Type
Observational
Primary Outcome
Interview - AskBio009-101 Study - Participants/ Patients
Condition
Hemophilia B
Intervention
Qualitative Interview - Participants/ Patients
Study Arms / Comparison Groups
Participants/ Patients
Description: Participants/ Patients from the AskBio009-101 Study
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
27
Start Date
March 31, 2017
Completion Date
June 6, 2017
Primary Completion Date
June 6, 2017
Eligibility 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
Gender
All
Ages
18 Years - 75 Years
Accepts Healthy Volunteers
No
Contacts
John Chapin, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT03054389
Organization ID
001601
Responsible Party
Sponsor
Study Sponsor
Baxalta now part of Shire
Study Sponsor
John Chapin, MD, Study Director, Baxalta now part of Shire
Verification Date
June 2017