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

Sponsor
Baxalta now part of Shire (Industry)
Overall Status
Completed
CT.gov ID
NCT03054389
Collaborator
(none)
27
1
2.2
12.3

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
  • Other: Qualitative Interview - Participants/ Patients
  • Other: Qualitative Interview - Investigators and Study Coordinators

Study Design

Study Type:
Observational
Actual Enrollment :
27 participants
Observational Model:
Other
Time Perspective:
Retrospective
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
Actual Study Start Date :
Mar 31, 2017
Actual Primary Completion Date :
Jun 6, 2017
Actual Study Completion Date :
Jun 6, 2017

Arms and Interventions

Arm Intervention/Treatment
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

  1. 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

  2. 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

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
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.
Responsible Party:
Baxalta now part of Shire
ClinicalTrials.gov Identifier:
NCT03054389
Other Study ID Numbers:
  • 001601
First Posted:
Feb 15, 2017
Last Update Posted:
Apr 23, 2021
Last Verified:
Apr 1, 2021
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 23, 2021