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

NCT03054389 | Completed

• 1 other identifier: 001601
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 1

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

Conditions

Hemophilia B

Outcome Measures

Primary Outcomes (2)

• Interview - AskBio009-101 Study - Participants/ Patients

  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

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

  Approximately 1 hour

Study Arms (2)

Participants/ Patients

Participants/ Patients from the AskBio009-101 Study

Other: Qualitative Interview - Participants/ Patients

Investigators and Study Coordinators

Investigators and Study Coordinators from the AskBio009-101 Study

Other: Qualitative Interview - Investigators and Study Coordinators

Interventions

Qualitative Interview - Participants/ Patients OTHER

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

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

Investigators and Study Coordinators

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• \- N/A
• 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
• \- Not directly involved in the consent process at the gene therapy site

Sponsors & Collaborators

• Baxalta now part of Shire: lead

Study Sites (1)

QuintilesIMS

Cambridge, Massachusetts, 02139, United States

Location

MeSH Terms

Conditions

Hemophilia B

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, X-Linked

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2017
• First Posted: February 15, 2017
• Study Start: March 31, 2017
• Primary Completion: June 6, 2017
• Study Completion: June 6, 2017
• Last Updated: April 23, 2021

Record last verified: 2021-04

Locations

US (1)