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NCT03054389 Clinical Trial

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

Hemophilia B Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03054389
Other study ID # 001601
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 31, 2017
Est. completion date June 6, 2017

Study information
Verified date April 2021
Source Takeda
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 27
Est. completion date June 6, 2017
Est. primary completion date June 6, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States QuintilesIMS Cambridge Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Baxalta now part of Shire

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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
See also
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Terminated NCT01620801 - Hemophilia B Gene Therapy With AAV8 Vector Phase 1
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