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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
Enrollment
1
Location
2.2
Actual Duration (Months)
12.3
Patients Per Site Per Month

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:
Hemophilia A
Hemophilia B

Study Results

No Results Posted as of Apr 23, 2021