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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03054389
Recruitment Status : Completed
First Posted : February 15, 2017
Last Update Posted : October 23, 2017
Sponsor:
Information provided by (Responsible Party):
Shire ( Baxalta now part of Shire )

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

Condition or disease Intervention/treatment
Hemophilia B Other: Qualitative Interview - Participants/ Patients Other: Qualitative Interview - Investigators and Study Coordinators

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Study Type : Observational
Actual Enrollment : 27 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Non-Interventional Study to Capture the Patient Experience on Gene Therapy for Hemophilia Within the AskBio009-101 Study Through Patient and Investigator Interviews
Actual Study Start Date : March 31, 2017
Actual Primary Completion Date : June 6, 2017
Actual Study Completion Date : June 6, 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Participants/ Patients
Participants/ Patients from the AskBio009-101 Study
Other: Qualitative Interview - Participants/ Patients
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
Other: Qualitative Interview - Investigators and Study Coordinators
Qualitative interviews to understand the patient experience with the AskBio009-101 Study - Investigators and Study Coordinators




Primary Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Investigators, Study Coordinators, and Participants from the AskBio009-101 Study
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03054389


Locations
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United States, Massachusetts
QuintilesIMS
Cambridge, Massachusetts, United States, 02139
Sponsors and Collaborators
Baxalta now part of Shire
Investigators
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Study Director: John Chapin, MD Baxalta now part of Shire
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Responsible Party: Baxalta now part of Shire
ClinicalTrials.gov Identifier: NCT03054389    
Other Study ID Numbers: 001601
First Posted: February 15, 2017    Key Record Dates
Last Update Posted: October 23, 2017
Last Verified: June 2017
Additional relevant MeSH terms:
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Hemophilia A
Hemophilia B
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Genetic Diseases, X-Linked