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

NCT03054389 — Completed, 27 participants, Baxalta now part of Shire

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Registry	NCT03054389
Status	Completed
Study type	Observational
Enrollment	27 (Actual)
Sponsor	Baxalta now part of Shire (Industry)
Conditions	Hemophilia B
Interventions	Qualitative Interview - Participants/ Patients, Qualitative Interview - Investigators and Study Coordinators (Other)
Dates	start 2017-03-31, primary completion 2017-06-06, completion 2017-06-06, first posted 2017-02-15, last updated 2021-04-23
Locations	1 site in United States

-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

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+Arms and interventions

Arm	Type	Interventions	Description
Participants/ Patients		Other: Qualitative Interview - Participants/ Patients	Participants/ Patients from the AskBio009-101 Study
Investigators and Study Coordinators		Other: Qualitative Interview - Investigators and Study Coordinators	Investigators and Study Coordinators from the AskBio009-101 Study

Qualitative Interview - Participants/ Patients (Other): Qualitative interviews to understand the patient experience with the AskBio009-101 Study - Participants/ Patients
Qualitative Interview - Investigators and Study Coordinators (Other): Qualitative interviews to understand the patient experience with the AskBio009-101 Study - Investigators and Study Coordinators

+Outcome measures

Primary outcomes

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

Sex: All, ages: 18 Years to 75 Years

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

+Locations (1)

Facility	City	Country	Status
QuintilesIMS	Cambridge, Massachusetts	United States

+Investigators

Study Director, Study director, Takeda