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OpenTrials
Completed

NCT Number: NCT03054389

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

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

Completed

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Qualitative Interview - Participants/ Patients

Other

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

Qualitative Interview - Investigators and Study Coordinators

Other

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

Primary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Baxalta now part of Shire

Industry

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Feb 15, 2017
Registry last updated
Apr 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.