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

Completed

• Conditions: Hemophilia B
• Interventions: Other: Qualitative Interview - Investigators and Study Coordinators; Other: Qualitative Interview - Participants/ Patients

• Registration Number: NCT03054389
• Lead Sponsor: Baxalta now part of Shire

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-02-13
• Study First Submitted QC: 2017-02-13
• Study First Posted: 2017-02-15
• Study Start: 2017-03-31
• Primary Completion: 2017-06-06
• Study Completion: 2017-06-06
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-21
• Last Update Posted: 2021-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Investigators and Study Coordinators	Qualitative Interview - Investigators and Study Coordinators	Investigators and Study Coordinators from the AskBio009-101 Study
Participants/ Patients	Qualitative Interview - Participants/ Patients	Participants/ Patients from the AskBio009-101 Study

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

QuintilesIMS; 🇺🇸 Cambridge, Massachusetts, United States