Hemophilia BNCT03054389
Non-Interventional Study to Capture the Patient Experience on Gene Therapy for Hemophilia Within the AskBio009-101 Study Through Patient and Investigator Interviews
An observational study of Hemophilia B, run by Baxalta now part of Shire at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hemophilia B
- What is being tested?
- Qualitative Interview - Participants/ Patients and Qualitative Interview - Investigators and Study Coordinators
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Mar 2017to 6 Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Investigators, Study Coordinators, and Participants from the AskBio009-101 Study
Who may be able to join
- 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
- Worked at a site as an investigator or study coordinator that consented a patient into the
Show all 10Show fewer
- 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
Who cannot join
- N/A
- Not directly involved in the consent process at the gene therapy site
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Qualitative Interview - Participants/ Patients, Qualitative Interview - Investigators and Study Coordinators
- Medical subject headings
- Hemophilia B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qualitative Interview - Participants/ PatientsOther
Qualitative interviews to understand the patient experience with the AskBio009-101 Study - Participants/ Patients
Qualitative Interview - Investigators and Study CoordinatorsOther
Qualitative interviews to understand the patient experience with the AskBio009-101 Study - Investigators and Study Coordinators
| Study group | Role | What they receive |
|---|---|---|
| Participants/ Patients | Participants/ Patients from the AskBio009-101 Study Receives: Other: Qualitative Interview - Participants/ Patients | |
| Investigators and Study Coordinators | Investigators and Study Coordinators from the AskBio009-101 Study Receives: Other: Qualitative Interview - Investigators and Study Coordinators |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interview - AskBio009-101 Study - Participants/ Patients
Qualitative telephone interviews to understand the patient experience with the AskBio009-101 Study - Participant/ Patient Interview
Measured: 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
Measured: Approximately 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2017
- Study start31 Mar 2017
- Primary completion6 Jun 2017
- Study completion6 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemophilia BStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baxalta now part of Shire
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03054389
- Sponsor's protocol ID
- 001601
- Status last verified
- Apr 2021
- First submitted
- 13 Feb 2017
- Last updated
- 23 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03054389
- Acronym / sponsor ID
- 001601
- Conditions
- Hemophilia B
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Baxalta now part of ShireIndustry (pharma, biotech, devices)
- Study start
- 31 Mar 2017 (actual)
- Primary completion
- 6 Jun 2017 (actual)
- Study completion
- 6 Jun 2017 (actual)
- First posted
- 15 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants/ Patients | – | Other: Qualitative Interview - Participants/ PatientsParticipants/ Patients from the AskBio009-101 Study |
| Investigators and Study Coordinators | – | Other: Qualitative Interview - Investigators and Study CoordinatorsInvestigators and Study Coordinators from the AskBio009-101 Study |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Investigators, Study Coordinators, and Participants from the AskBio009-101 Study
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (2 listed)
- N/A
- Not directly involved in the consent process at the gene therapy site
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Qualitative Interview - Participants/ PatientsQualitative interviews to understand the patient experience with the AskBio009-101 Study - Participants/ Patients | Other | Participants/ Patients |
| Qualitative Interview - Investigators and Study CoordinatorsQualitative interviews to understand the patient experience with the AskBio009-101 Study - Investigators and Study Coordinators | Other | Investigators and Study Coordinators |
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Takeda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemophilia B, run by Baxalta now part of Shire at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interview - AskBio009-101 Study - Participants/ Patients (time frame: Approximately 1 hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2021.