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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

Plain-language summary

This non-interventional study seeks to understand patients' perspectives around the decision to take part in a clinical trial for a hemophilia therapy. Data are collected through qualitative interviews with participants/patients and with investigators and study coordinators. To take part, individuals must have been screened and consented for the AskBio009-101 study, speak and understand English, be between 18 and 75 years old, and be physically able to complete a one-hour phone interview.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase
N/A
Status
Completed
Sponsor
Baxalta now part of Shire
Intervention
Qualitative Interview - Participants/ Patients, Qualitative Interview - Investigators and Study Coordinators
Start date
3/31/2017
Estimated completion
6/6/2017
Countries
United States

Related genes

Locations

  • Cambridge, United States

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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
This is not medical advice. Consult your specialist.
View the official record on ClinicalTrials.gov →