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

NCT ID: NCT03054389

Last Updated: 2021-04-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

27 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-03-31

Study Completion Date

2017-06-06

Brief Summary

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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

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Conditions

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Hemophilia B

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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Participants/ Patients

Participants/ Patients from the AskBio009-101 Study

Qualitative Interview - Participants/ Patients

Intervention Type OTHER

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

Qualitative Interview - Investigators and Study Coordinators

Intervention Type OTHER

Qualitative interviews to understand the patient experience with the AskBio009-101 Study - Investigators and Study Coordinators

Interventions

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Qualitative Interview - Participants/ Patients

Qualitative interviews to understand the patient experience with the AskBio009-101 Study - Participants/ Patients

Intervention Type OTHER

Qualitative Interview - Investigators and Study Coordinators

Qualitative interviews to understand the patient experience with the AskBio009-101 Study - Investigators and Study Coordinators

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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


* 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

\- N/A


\- Not directly involved in the consent process at the gene therapy site
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Baxalta now part of Shire

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

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QuintilesIMS

Cambridge, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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001601

Identifier Type: -

Identifier Source: org_study_id

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