Congenital Bleeding DisorderHERONCT01322620
Survey Evaluating the Psychosocial Effects of Living With Haemophilia
An observational study of Congenital Bleeding Disorder and Haemophilia A, run by Novo Nordisk A/S at 3 sites in 3 countries.
Trial summary
This study is conducted in Africa, Asia, Europe, North America and South America. The purpose of the survey is to identify the key psychosocial issues affecting patients with haemophilia. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Congenital Bleeding Disorder, Haemophilia A, Haemophilia B
- What is being tested?
- No treatment given
- How many people
- 1,236 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 3 Jun 2011to 29 Feb 2012
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Adult males with haemophilia and parents/carers of children with haemophilia.
Who may be able to join
- Males with haemophilia A or B (with or without inhibitors)
- Parents/carers of children aged below 18 years with haemophilia A or B (with or without inhibitors)
- Patients currently receiving treatment for haemophilia with one of the following: replacement factor VIII or replacement factor IX or a bypassing agent (recombinant factor VIIa or aPCC (Activated prothrombin complex concentrate))
- Patients with haemophilia, not currently receiving treatment with replacement factor VIII or IX or a bypassing agent (as appropriate), but who have had at least one spontaneous bleed into one or more joints within the last 12 months
- Subjects must have access to the internet, either at home or at a location convenient to them, be able to complete a paper questionnaire, or be available to attend a face-to-face interview (Algerian subjects only), to participate in the survey
Who cannot join
- Inability to understand and comply with written and verbal instructions unless assisted at the haemophilia treatment centre (HTC) or by a relative
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
United Kingdom1 site
Novo Nordisk Investigational Site
Crawley, RH11 9RT
About this study
Official title: Haemophilia, Experiences, Results and Opportunities (HERO): A Community-based Evaluation of the Psychosocial Effects of Haemophilia on Patients and Their Carers
This study is conducted in Africa, Asia, Europe, North America and South America.
The purpose of the survey is to identify the key psychosocial issues affecting patients with haemophilia.
- Conditions
- Congenital Bleeding Disorder, Haemophilia A, Haemophilia B, Haemophilia A With Inhibitors, Haemophilia B With Inhibitors, Relatives to/Carers of Patients
- Being tested
- No treatment given
- Medical subject headings
- Hemophilia A, Hemophilia B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No treatment givenOther
No treatment given. Participants are to complete a questionnarie in the study.
| Study group | Role | What they receive |
|---|---|---|
| A | Not described Receives: Other: No treatment given |
What is being measured
The primary outcome is the main question the study is designed to answer.
To quantify the extent of key psychosocial factors affecting patients with haemophilia in their daily lives
Measured: After 6 weeks (recruitment and data collection)
Secondary outcomes (1)
To quantify how psychosocial factors are associated with treatment outcomes, compliance, health and general well-being
Measured: After 6 weeks (recruitment and data collection)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2011 (estimated)
- Study start3 Jun 2011
- Primary completion29 Feb 2012
- Study completion29 Feb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Congenital Bleeding DisorderStudies 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
- Cross-sectional
- Enrolment
- 1,236 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
- NCT01322620
- Sponsor's protocol ID
- F7HAEM-3911
- Other IDs
- U1111-1119-7128
- Acronym
- HERO
- Status last verified
- Feb 2017
- First submitted
- 23 Mar 2011
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Forsyth AL, Gregory M, Nugent D, Garrido C, Pilgaard T, Cooper DL, Iorio A. Haemophilia Experiences, Results and Opportunities (HERO) Study: survey methodology and population demographics. Haemophilia. 2014 Jan;20(1):44-51. doi: 10.1111/hae.12239. Epub 2013 Aug 1.
PubMed 23902228Witkop M, Guelcher C, Forsyth A, Hawk S, Curtis R, Kelley L, Frick N, Rice M, Rosu G, Cooper DL. Treatment outcomes, quality of life, and impact of hemophilia on young adults (aged 18-30 years) with hemophilia. Am J Hematol. 2015 Dec;90 Suppl 2:S3-10. doi: 10.1002/ajh.24220.
PubMed 26619194
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Haemophilia, Experiences, Results and Opportunities (HERO): A Community-based Evaluation of the Psychosocial Effects of Haemophilia on Patients and Their Carers
- ClinicalTrials.gov ID
- NCT01322620
- Acronym / sponsor ID
- HERO / F7HAEM-3911
- Conditions
- Congenital Bleeding Disorder, Haemophilia A, Haemophilia B, Haemophilia A With Inhibitors, Haemophilia B With Inhibitors, Relatives to/Carers of Patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,236 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 3 Jun 2011 (actual)
- Primary completion
- 29 Feb 2012 (actual)
- Study completion
- 29 Feb 2012 (actual)
- First posted
- 24 Mar 2011 (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 Africa, Asia, Europe, North America and South America.
The purpose of the survey is to identify the key psychosocial issues affecting patients with haemophilia.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | – | Other: No treatment given |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult males with haemophilia and parents/carers of children with haemophilia.
Key inclusion criteria (5 listed)
- Males with haemophilia A or B (with or without inhibitors)
- Parents/carers of children aged below 18 years with haemophilia A or B (with or without inhibitors)
- Patients currently receiving treatment for haemophilia with one of the following: replacement factor VIII or replacement factor IX or a bypassing agent (recombinant factor VIIa or aPCC (Activated prothrombin complex concentrate))
- Patients with haemophilia, not currently receiving treatment with replacement factor VIII or IX or a bypassing agent (as appropriate), but who have had at least one spontaneous bleed into one or more joints within the last 12 months
- Subjects must have access to the internet, either at home or at a location convenient to them, be able to complete a paper questionnaire, or be available to attend a face-to-face interview (Algerian subjects only), to participate in the survey
Key exclusion criteria (1 listed)
- Inability to understand and comply with written and verbal instructions unless assisted at the haemophilia treatment centre (HTC) or by a relative
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 givenNo treatment given. Participants are to complete a questionnarie in the study. | Other | A |
Primary outcome
To quantify the extent of key psychosocial factors affecting patients with haemophilia in their daily lives
Time frame: After 6 weeks (recruitment and data collection)
1 secondary outcome
To quantify how psychosocial factors are associated with treatment outcomes, compliance, health and general well-being
Time frame: After 6 weeks (recruitment and data collection)
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 Feb 2017.
- Results publication: PubMed 23902228Forsyth AL, Gregory M, Nugent D, Garrido C, Pilgaard T, Cooper DL, Iorio A. Haemophilia Experiences, Results and Opportunities (HERO) Study: survey methodology and population demographics. Haemophilia. 2014 Jan;20(1):44-51. doi: 10.1111/hae.12239. Epub 2013 Aug 1.
- Results publication: PubMed 26619194Witkop M, Guelcher C, Forsyth A, Hawk S, Curtis R, Kelley L, Frick N, Rice M, Rosu G, Cooper DL. Treatment outcomes, quality of life, and impact of hemophilia on young adults (aged 18-30 years) with hemophilia. Am J Hematol. 2015 Dec;90 Suppl 2:S3-10. doi: 10.1002/ajh.24220.
- 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
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Bleeding Disorder and Haemophilia A, run by Novo Nordisk A/S at 3 sites in 3 countries.
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 5 inclusion and 1 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 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada, Spain, United Kingdom. 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?
To quantify the extent of key psychosocial factors affecting patients with haemophilia in their daily lives (time frame: After 6 weeks (recruitment and data collection)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01322620, which also lists 2 linked publications.
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 Feb 2017.