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
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Hemophilia A
• Hemophilia B

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