HaemostasisNCT02568202
Bridging Hemophilia B Experiences, Results and Opportunities Into Solutions (B-HERO-S)
An observational study of Haemostasis and Congenital Bleeding Disorder, run by Novo Nordisk A/S at 1 site in United States.
Trial summary
This study is conducted in the United States of America (USA). Tha aim of this study is bridging Hemophilia B Experiences, Results and Opportunities into Solutions (B-HERO-S). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Haemostasis, Congenital Bleeding Disorder, Haemophilia B
- What is being tested?
- No treatment given
- How many people
- 449 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to Nov 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will investigate adult patients at least 18 years of age with mild-severe hemophilia B and caregivers of children (current age below 18 years) with hemophilia B.
Who may be able to join
- Adults aged below or equal to 18 years with hemophilia B (any severity, with or without inhibitors)
- Caregivers of children currently aged below 18 years with hemophilia B (any severity, with or without inhibitors)
- Subjects must have access to the internet, either at home or at a location convenient to them
- Provision of informed consent before the start of any survey-related activities
Who cannot join
- Inability to understand and comply with written instructions in English
- Previous completion of the B-HERO-S study with receipt of compensation
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
Trial locations and contacts
1 site in 1 country.
United States1 site
Novo Nordisk Clinical Trial Call Center
Plainsboro, New Jersey, 08536
About this study
This study is conducted in the United States of America (USA). Tha aim of this study is bridging Hemophilia B Experiences, Results and Opportunities into Solutions (B-HERO-S).
- Conditions
- Haemostasis, Congenital Bleeding Disorder, Haemophilia B
- Being tested
- No treatment given
- Medical subject headings
- Hemophilia B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No treatment givenOther
This is an online web-based cross-sectional survey in which participants will complete one of two questionnaires.
There will be no treatment.
| Study group | Role | What they receive |
|---|---|---|
| Survey | Not described Receives: Other: No treatment given |
What is being measured
The primary outcome is the main question the study is designed to answer.
An online survey of Prevalence and characteristics of adults with hemophilia B
Measured: At day 0
An online survey of Prevalence and characteristics of children with hemophilia B (and their parents)
Measured: At day 0
An online survey of Prevalence of psychosocial and other comorbidities in patients with hemophilia B
Measured: At day 0
Secondary outcomes (12)
Percentage of participants reporting difficulty with access to treatment (e.g. factor)
Measured: At day 0
An online survey of Percentage of participants reporting difficulty with access to treatment centers
Measured: At day 0
Percentage of participants reporting hemophilia interference with employment/education
Measured: At day 0
Percentage of participants reporting hemophilia interference with physical activities
Measured: At day 0
Percentage of participants reporting hemophilia interference with relationships
Measured: At day 0
Health related quality of life: EuroQol
Measured: At day 0
Health related quality of life:EQ-5D-5L
Measured: At day 0
Health related quality of life: VAS (Visual Analog Scale)
Measured: At day 0
Health related quality of life: BPI (Brief Pain Inventory) short form - Pain severity and interference
Measured: At day 0
Health related quality of life: HAL (Hemophilia Activities List)
Measured: At day 0
Health related quality of life: HemoCAB (Caregiver Hemophilia Burden Scale
Measured: At day 0
Drivers of psychosocial impact (e.g. hemophilia severity, age, weight, prior treatment history, education)
Measured: At day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2015 (estimated)
- Study startSep 2015
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HaemostasisStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 449 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Registry (GCR, 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02568202
- Sponsor's protocol ID
- HAEM-4268
- Other IDs
- U1111-1171-8168
- Status last verified
- Jan 2016
- First submitted
- 18 Sep 2015
- Last updated
- 12 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bridging Hemophilia B Experiences, Results and Opportunities Into Solutions (B-HERO-S)
- ClinicalTrials.gov ID
- NCT02568202
- Acronym / sponsor ID
- HAEM-4268
- Conditions
- Haemostasis, Congenital Bleeding Disorder, Haemophilia B
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 449 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Sep 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 5 Oct 2015 (estimated)
- 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.
This study is conducted in the United States of America (USA). Tha aim of this study is bridging Hemophilia B Experiences, Results and Opportunities into Solutions (B-HERO-S).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Survey | – | Other: No treatment given |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will investigate adult patients at least 18 years of age with mild-severe hemophilia B and caregivers of children (current age below 18 years) with hemophilia B.
Key inclusion criteria (4 listed)
- Adults aged below or equal to 18 years with hemophilia B (any severity, with or without inhibitors)
- Caregivers of children currently aged below 18 years with hemophilia B (any severity, with or without inhibitors)
- Subjects must have access to the internet, either at home or at a location convenient to them
- Provision of informed consent before the start of any survey-related activities
Key exclusion criteria (3 listed)
- Inability to understand and comply with written instructions in English
- Previous completion of the B-HERO-S study with receipt of compensation
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
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 |
|---|---|---|
| No treatment givenThis is an online web-based cross-sectional survey in which participants will complete one of two questionnaires. There will be no treatment. | Other | Survey |
Primary outcome
An online survey of Prevalence and characteristics of adults with hemophilia B
Time frame: At day 0
An online survey of Prevalence and characteristics of children with hemophilia B (and their parents)
Time frame: At day 0
An online survey of Prevalence of psychosocial and other comorbidities in patients with hemophilia B
Time frame: At day 0
12 secondary outcomes
Percentage of participants reporting difficulty with access to treatment (e.g. factor)
Time frame: At day 0
An online survey of Percentage of participants reporting difficulty with access to treatment centers
Time frame: At day 0
Percentage of participants reporting hemophilia interference with employment/education
Time frame: At day 0
Percentage of participants reporting hemophilia interference with physical activities
Time frame: At day 0
Percentage of participants reporting hemophilia interference with relationships
Time frame: At day 0
Health related quality of life: EuroQol
Time frame: At day 0
Health related quality of life:EQ-5D-5L
Time frame: At day 0
Health related quality of life: VAS (Visual Analog Scale)
Time frame: At day 0
Health related quality of life: BPI (Brief Pain Inventory) short form - Pain severity and interference
Time frame: At day 0
Health related quality of life: HAL (Hemophilia Activities List)
Time frame: At day 0
Health related quality of life: HemoCAB (Caregiver Hemophilia Burden Scale
Time frame: At day 0
Drivers of psychosocial impact (e.g. hemophilia severity, age, weight, prior treatment history, education)
Time frame: At day 0
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 12 Jan 2016.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
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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.
Global Clinical Registry (GCR, 1452) study director
Novo Nordisk A/S
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 Haemostasis and Congenital Bleeding Disorder, run by Novo Nordisk A/S 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 4 inclusion and 3 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 12 Jan 2016. 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?
An online survey of Prevalence and characteristics of adults with hemophilia B (time frame: At day 0). The study lists 3 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 12 Jan 2016.