Congenital Bleeding DisorderHAEMOcareNCT01503567
Epidemiological Study on Haemophilia Care and Orthopaedic Status in Developing Countries
An observational study of Congenital Bleeding Disorder and Haemophilia A, run by Novo Nordisk A/S at 4 sites in 4 countries.
Trial summary
This study is conducted in Africa and Asia. The aim of this study is to evaluate in the participating countries the orthopaedic status and the degree of arthropathy of severe haemophilia patients in general. Read more about this study
- Who is it for?
- Ages 6 to 18 years, men only
- Conditions the study is for
- Congenital Bleeding Disorder, Haemophilia A, Haemophilia A With Inhibitors
- What is being tested?
- No treatment given
- How many people
- 282 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Jan 2012to Sep 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 6 to 18 years
- Men only
- No healthy volunteers
- Child, Adult
Study population: Male patients at least 6 years old with severe congenital haemophilia A or B (FVIII or FIX activities below 1% or level below 1U dL^-1) without inhibitor or with inhibitors against FVIII or FIX
Who may be able to join
- Patient (and/or parents or the patient's legally acceptable representative, if applicable) must give signed and dated informed consent before enrolment in the study
- Male patients at least 6 years old with diagnosis of severe congenital haemophilia A or B with or without inhibitors
- Patients receiving on demand replacement factors/bypassing agents therapy
Who cannot join
- Clinically relevant coagulation disorders other than congenital haemophilia A or B
- Patients on currently active treatment for HCV (Hepatitis C Virus) or HIV (Human Immune Deficiency Virus) infections
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
About this study
This study is conducted in Africa and Asia. The aim of this study is to evaluate in the participating countries the orthopaedic status and the degree of arthropathy of severe haemophilia patients in general.
- Conditions
- Congenital Bleeding Disorder, Haemophilia A, Haemophilia A With Inhibitors, Haemophilia B, Haemophilia B With Inhibitors
- 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
Subject will only fill out a questionaire
| Study group | Role | What they receive |
|---|---|---|
| Subjects 6 to 18 years old without inhibitors | Not described Receives: Other: No treatment given | |
| Subjects 6 to 18 years old with inhibitors | Not described Receives: Other: No treatment given | |
| Subjects above18 years old without inhibitors | Not described Receives: Other: No treatment given | |
| Subjects above 18 years old with inhibitors | Not described Receives: Other: No treatment given |
What is being measured
The primary outcome is the main question the study is designed to answer.
Type of haemophilia and inhibitor characteristics: Against FVIII or FIX; high or low titre; anamnestic response (high or low responder)
Measured: After 6 months (recruitment and data collection)
Clinical (using Haemophilia joint score) and radiological (using Pettersson score) orthopaedic status of defined joints: Elbow, knees and ankles in relation to haemophilia A or B
Measured: After 6 months (recruitment and data collection)
Secondary outcomes (5)
Mean orthopaedic score in the 4 groups according to the Pettersson and Haemophilia joint scores
Measured: After 6 months (recruitment and data collection)
Usage of anti haemophilic treatment in IU/kg
Measured: During the last year preceding patient recruitment
Quality of Life - EQ-5D (Euro Quality - 5 Domains) questionnaire
Measured: After 6 months (recruitment and data collection)
Economic aspects of the management of haemophiliacs and its burden on patient/family and community resources
Measured: After 6 months (recruitment and data collection)
Living characteristics of the patient's household
Measured: After 6 months (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 posted4 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 282 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
- NCT01503567
- Sponsor's protocol ID
- HAEM-3971
- Other IDs
- U1111-1124-6665
- Acronym
- HAEMOcare
- Status last verified
- Jan 2017
- First submitted
- 2 Jan 2012
- Last updated
- 18 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Gupta N, Belhani M, Benbouzid A, Andaloussi M El, Maani K, Mahlangu J, Wali Y, Saad HA, Fegoun SB el. The Haemocare Protocol - A composite method to measure the disease burden from Haemophilia in developing countries. European Hematology Association 2013; Country: Sweden City: Stockholm
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiological Study on Haemophilia Care and Orthopaedic Status in Developing Countries
- ClinicalTrials.gov ID
- NCT01503567
- Acronym / sponsor ID
- HAEMOcare / HAEM-3971
- Conditions
- Congenital Bleeding Disorder, Haemophilia A, Haemophilia A With Inhibitors, Haemophilia B, Haemophilia B With Inhibitors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 282 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 4 Jan 2012 (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 and Asia. The aim of this study is to evaluate in the participating countries the orthopaedic status and the degree of arthropathy of severe haemophilia patients in general.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Subjects 6 to 18 years old without inhibitors | – | Other: No treatment given |
| Subjects 6 to 18 years old with inhibitors | – | Other: No treatment given |
| Subjects above18 years old without inhibitors | – | Other: No treatment given |
| Subjects above 18 years old with inhibitors | – | Other: No treatment given |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Male patients at least 6 years old with severe congenital haemophilia A or B (FVIII or FIX activities below 1% or level below 1U dL^-1) without inhibitor or with inhibitors against FVIII or FIX
Key inclusion criteria (3 listed)
- Patient (and/or parents or the patient's legally acceptable representative, if applicable) must give signed and dated informed consent before enrolment in the study
- Male patients at least 6 years old with diagnosis of severe congenital haemophilia A or B with or without inhibitors
- Patients receiving on demand replacement factors/bypassing agents therapy
Key exclusion criteria (2 listed)
- Clinically relevant coagulation disorders other than congenital haemophilia A or B
- Patients on currently active treatment for HCV (Hepatitis C Virus) or HIV (Human Immune Deficiency Virus) infections
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 givenSubject will only fill out a questionaire | Other | Subjects 6 to 18 years old with inhibitors, Subjects 6 to 18 years old without inhibitors, Subjects above 18 years old with inhibitors, Subjects above18 years old without inhibitors |
Primary outcome
Type of haemophilia and inhibitor characteristics: Against FVIII or FIX; high or low titre; anamnestic response (high or low responder)
Time frame: After 6 months (recruitment and data collection)
Clinical (using Haemophilia joint score) and radiological (using Pettersson score) orthopaedic status of defined joints: Elbow, knees and ankles in relation to haemophilia A or B
Time frame: After 6 months (recruitment and data collection)
5 secondary outcomes
Mean orthopaedic score in the 4 groups according to the Pettersson and Haemophilia joint scores
Time frame: After 6 months (recruitment and data collection)
Usage of anti haemophilic treatment in IU/kg
Time frame: During the last year preceding patient recruitment
Quality of Life - EQ-5D (Euro Quality - 5 Domains) questionnaire
Time frame: After 6 months (recruitment and data collection)
Economic aspects of the management of haemophiliacs and its burden on patient/family and community resources
Time frame: After 6 months (recruitment and data collection)
Living characteristics of the patient's household
Time frame: After 6 months (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 18 Jan 2017.
- Results publicationGupta N, Belhani M, Benbouzid A, Andaloussi M El, Maani K, Mahlangu J, Wali Y, Saad HA, Fegoun SB el. The Haemocare Protocol - A composite method to measure the disease burden from Haemophilia in developing countries. European Hematology Association 2013; Country: Sweden City: Stockholm
- 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
4 sites in 4 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 4 sites in 4 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 3 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 18 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in India, Morocco, Oman, South Africa. 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?
Type of haemophilia and inhibitor characteristics: Against FVIII or FIX; high or low titre; anamnestic response (high or low responder) (time frame: After 6 months (recruitment and data collection)). 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?
On the ClinicalTrials.gov record for NCT01503567, which also lists 1 linked publication.
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 18 Jan 2017.