Hemophilia B Clinical Trial
— B-MOREOfficial title:
A 24-month Prospective, Non-interventional, International, Multicentre Study to Describe the Real-world Effectiveness and Usage of Alprolix in Patients With Haemophilia B
| Verified date | January 2024 |
| Source | Swedish Orphan Biovitrum |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
Alprolix (rFIXFc) is a recombinant extended half-life coagulation factor product. The purpose of this non-interventional study is to describe the real-world usage and effectiveness of Alprolix in the on-demand and prophylactic treatment of haemophilia B.
| Status | Active, not recruiting |
| Enrollment | 151 |
| Est. completion date | May 31, 2024 |
| Est. primary completion date | May 31, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility | Inclusion Criteria: - Have a diagnosis of haemophilia B - Have started Alprolix treatment prior to enrolment visit, or at enrolment prescribed treatment with Alprolix irrespective of participation in the study - Signed and dated informed consent provided by the patient, or the patient's legally acceptable representative for patients under the legal age, before any study-related activities are undertaken. Assent should be obtained from paediatric patients according to local regulations. Exclusion Criteria: - Participation in an investigational medicinal product trial at enrolment visit |
| Country | Name | City | State |
|---|---|---|---|
| Czechia | Swedish Orphan Biovitrum Research Site | Brno | |
| Czechia | Swedish Orphan Biovitrum Research Site | Prague | |
| Greece | Swedish Orphan Biovitrum Research Site (Haemophilia Center Aghia Sophia Children's Hospital) | Athens | |
| Greece | Swedish Orphan Biovitrum Research Site (Laik? General Hospital of Athens) | Athens | |
| Ireland | Swedish Orphan Biovitrum Research Site | Dublin | |
| Italy | Swedish Orphan Biovitrum Research Site | Bari | |
| Italy | Swedish Orphan Biovitrum Research Site | Florence | |
| Italy | Swedish Orphan Biovitrum Research Site | Genova | |
| Italy | Swedish Orphan Biovitrum Research Site | Milan | |
| Italy | Swedish Orphan Biovitrum Research Site | Roma | |
| Italy | Swedish Orphan Biovitrum Research Site | Turin | |
| Norway | Swedish Orphan Biovitrum Research Site | Oslo | |
| Saudi Arabia | Swedish Orphan Biovitrum Research Site (King Faisal Hospital adult) | Riyadh | |
| Saudi Arabia | Swedish Orphan Biovitrum Research Site (King Faisal Hospital pediatric) | Riyadh | |
| Spain | Swedish Orphan Biovitrum Research Site (Hospital de Vall d'Hebrón) | Barcelona | |
| Spain | Swedish Orphan Biovitrum Research Site (Hospital Sant Joan de Deu) | Barcelona | |
| Spain | Swedish Orphan Biovitrum Research Site | Murcia | |
| Spain | Swedish Orphan Biovitrum Research Site | Vigo | |
| Sweden | Swedish Orphan Biovitrum Research Site | Gothenburg | |
| Sweden | Swedish Orphan Biovitrum Research Site | Malmö | |
| Sweden | Swedish Orphan Biovitrum Research Site (Karolinska University Hospital adult) | Stockholm | |
| Sweden | Swedish Orphan Biovitrum Research Site (Karolinska University Hospital pediatric) | Stockholm | |
| United Kingdom | Swedish Orphan Biovitrum Research Site | Hull | |
| United Kingdom | Swedish Orphan Biovitrum Research Site | London | |
| United Kingdom | Swedish Orphan Biovitrum Research Site | London | |
| United Kingdom | Swedish Orphan Biovitrum Research Site | London | |
| United Kingdom | Swedish Orphan Biovitrum Research Site | London | |
| United Kingdom | Swedish Orphan Biovitrum Research Site | Manchester | |
| United Kingdom | Swedish Orphan Biovitrum Research Site | Oxford |
| Lead Sponsor | Collaborator |
|---|---|
| Swedish Orphan Biovitrum | Cerner Enviza |
Czechia, Greece, Ireland, Italy, Norway, Saudi Arabia, Spain, Sweden, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Annualised bleeding rate (ABR) | Bleeding episodes assessed according to local practice | 24 months | |
| Primary | Annualised injection frequency | Assessed by prescription | 24 months | |
| Primary | Annualised factor consumption | Assessed by dispensed factor product | 24 months |
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