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

April 21, 2021 updated by: Baxalta now part of Shire
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

27

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Cambridge, Massachusetts, United States, 02139
        • QuintilesIMS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Investigators, Study Coordinators, and Participants from the AskBio009-101 Study

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Interview - AskBio009-101 Study - Participants/ Patients
Time Frame: Approximately 1 hour
Qualitative telephone interviews to understand the patient experience with the AskBio009-101 Study - Participant/ Patient Interview
Approximately 1 hour
Interview - AskBio009-101 Study - Investigators and Study Coordinators
Time Frame: Approximately 1 hour
Qualitative telephone interviews to understand the patient experience with the AskBio009-101 Study - Investigators and Study Coordinators Interview
Approximately 1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baxalta now part of Shire

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 31, 2017

Primary Completion (Actual)

June 6, 2017

Study Completion (Actual)

June 6, 2017

Study Registration Dates

First Submitted

February 13, 2017

First Submitted That Met QC Criteria

February 13, 2017

First Posted (Actual)

February 15, 2017

Study Record Updates

Last Update Posted (Actual)

April 23, 2021

Last Update Submitted That Met QC Criteria

April 21, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 001601

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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