Haemophilia ANCT02049099
A Non-interventional Retrospective Study of the Current Treatment Practice in European Haemophilia Care
An observational study of Haemophilia A and Haemophilia B, run by Swedish Orphan Biovitrum at 12 sites in 7 countries.
Trial summary
To describe the current treatment practice during 12 months for previously treated patients diagnosed with haemophilia A or haemophilia B. Read more about this study
- Who is it for?
- Ages 2 years and older, men only
- Conditions the study is for
- Haemophilia A, Haemophilia B
- How many people
- 1,658 participants
- Where
- 12 sitesin 7 countries
- Study dates
- Mar 2014to Sep 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 2 years and older
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population consists of patients with a diagnosis of ICD10: haemophilia A D66.9 or haemophilia B D67.9.
Who may be able to join
- Male patients with severe or moderate haemophilia A or haemophilia B.
- Treatment with Factor VIII/Factor IX products initiated at least 24 months before inclusion in the study.
- Informed consent is obtained from the patient or patient's legal representative (as applicable according to legal regulation).
Who cannot join
- Confirmed positive inhibitor test detected in the past 24 months.
Trial locations and contacts
12 sites in 7 countries.
12 sites in 7 countries
Italy3 sites
Swedish Orphan Biovitrum Investigational Site
Florence
Swedish Orphan Biovitrum Investigational Site
Milan
Swedish Orphan Biovitrum Investigational Site
Vicenza
France2 sites
Swedish Orphan Biovitrum Investigational Site
Montpellier
Swedish Orphan Biovitrum Investigational Site
Nantes
Germany2 sites
Swedish Orphan Biovitrum Investigational Site
Bonn
Swedish Orphan Biovitrum Investigational Site
Leipzig
Spain2 sites
Swedish Orphan Biovitrum Investigational Site
Barcelona
Swedish Orphan Biovitrum Investigational Site
Madrid
About this study
To describe the current treatment practice during 12 months for previously treated patients diagnosed with haemophilia A or haemophilia B.
Read the detailed description
The study population consists of patients with a diagnosis of ICD10: haemophilia A D66.9 or haemophilia B D67.9.
- Conditions
- Haemophilia A, Haemophilia B
- Medical subject headings
- Hemophilia A, Hemophilia B
What is being measured
The primary outcome is the main question the study is designed to answer.
Total dose (IU) issued of Factor VIII during a 12 month period
Measured: - 12 month to Day 0
Total dose (IU) issued of Factor IX during a 12 month period
Measured: - 12 month to Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2014 (estimated)
- Study startMar 2014
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Haemophilia AStudies of the same condition, open and under way.
- More trials run by Swedish Orphan BiovitrumThe 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
- Time perspective
- Retrospective
- Enrolment
- 1,658 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swedish Orphan Biovitrum
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stefan Lethagen, MD, Study director, Swedish Orphan Biovitrum AB (publ)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02049099
- Sponsor's protocol ID
- Sobi.HAEM89-001
- Status last verified
- Mar 2016
- First submitted
- 28 Jan 2014
- Last updated
- 14 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-interventional Retrospective Study of the Current Treatment Practice in European Haemophilia Care
- ClinicalTrials.gov ID
- NCT02049099
- Acronym / sponsor ID
- Sobi.HAEM89-001
- Conditions
- Haemophilia A, Haemophilia B
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,658 participants (actual)
- Lead sponsor
- Swedish Orphan BiovitrumIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 29 Jan 2014 (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.
To describe the current treatment practice during 12 months for previously treated patients diagnosed with haemophilia A or haemophilia B.
Detailed description
The study population consists of patients with a diagnosis of ICD10: haemophilia A D66.9 or haemophilia B D67.9.
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- 2 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population consists of patients with a diagnosis of ICD10: haemophilia A D66.9 or haemophilia B D67.9.
Key inclusion criteria (3 listed)
- Male patients with severe or moderate haemophilia A or haemophilia B.
- Treatment with Factor VIII/Factor IX products initiated at least 24 months before inclusion in the study.
- Informed consent is obtained from the patient or patient's legal representative (as applicable according to legal regulation).
Key exclusion criteria (1 listed)
- Confirmed positive inhibitor test detected in the past 24 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Total dose (IU) issued of Factor VIII during a 12 month period
Time frame: - 12 month to Day 0
Total dose (IU) issued of Factor IX during a 12 month period
Time frame: - 12 month to 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 14 Mar 2016.
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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.
Stefan Lethagen, MD study director
Swedish Orphan Biovitrum AB (publ)
12 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Haemophilia A and Haemophilia B, run by Swedish Orphan Biovitrum at 12 sites in 7 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 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 14 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Italy, France, Germany, Spain, Belgium and 2 more countries. 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?
Total dose (IU) issued of Factor VIII during a 12 month period (time frame: - 12 month to Day 0). 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 14 Mar 2016.