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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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03054389
Enrollment
27
Registered
2017-02-15
Start date
2017-03-31
Completion date
2017-06-06
Last updated
2021-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemophilia B

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

Interventions

OTHERQualitative Interview - Participants/ Patients

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

OTHERQualitative Interview - Investigators and Study Coordinators

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

Sponsors

Baxalta now part of Shire
Lead SponsorINDUSTRY

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Interview - AskBio009-101 Study - Participants/ PatientsApproximately 1 hourQualitative telephone interviews to understand the patient experience with the AskBio009-101 Study - Participant/ Patient Interview
Interview - AskBio009-101 Study - Investigators and Study CoordinatorsApproximately 1 hourQualitative telephone interviews to understand the patient experience with the AskBio009-101 Study - Investigators and Study Coordinators Interview

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026