Haemophilia B Clinical Trial
— B-SUREOfficial title:
A 24-month Prospective, Non-interventional, Multicentre Study to Evaluate the Real-world Effectiveness and Usage of Alprolix in Patients With Haemophilia B in France
| 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 | Completed |
| Enrollment | 91 |
| Est. completion date | March 16, 2022 |
| Est. primary completion date | March 16, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility | Inclusion Criteria: - Have a diagnosis of haemophilia B and been treated previously with factor IX Product - Have started Alprolix treatment prior to enrolment visit, or at enrolment prescribed treatment with Alprolix, regardless 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 |
|---|---|---|---|
| France | Swedish Orphan Biovitrum Research Site (CHU de Bordeaux) | Bordeaux | |
| France | Swedish Orphan Biovitrum Research Site | Brest | |
| France | Swedish Orphan Biovitrum Research Site | Caen | |
| France | Swedish Orphan Biovitrum Research Site | Chambéry | |
| France | Swedish Orphan Biovitrum Research Site | Clermont-Ferrand | |
| France | Swedish Orphan Biovitrum Research Site | Dijon | |
| France | Swedish Orphan Biovitrum Research Site | La Réunion | |
| France | Swedish Orphan Biovitrum Research Site | Lille | |
| France | Swedish Orphan Biovitrum Research Site | Marseille | |
| France | Swedish Orphan Biovitrum Research Site | Montpellier | |
| France | Swedish Orphan Biovitrum Research Site | Nantes | |
| France | Swedish Orphan Biovitrum Research Site | Nîmes | |
| France | Swedish Orphan Biovitrum research site | Paris | |
| France | Swedish Orphan Biovitrum research site | Poitiers | |
| France | Swedish Orphan Biovitrum research site | Rennes | |
| France | Swedish Orphan Biovitrum Research Site | Rouen | |
| France | Swedish Orphan Biovitrum research site | Strasbourg | |
| France | Swedish Orphan Biovitrum Research Site | Toulouse |
| Lead Sponsor | Collaborator |
|---|---|
| Swedish Orphan Biovitrum | Cerner Enviza |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Annualised bleeding rate (ABR) (prophylactic treatment) | Assessed by diary | 24 months | |
| Primary | Annualised injection frequency (prophylactic treatment) | Assessed by diary | 24 months | |
| Primary | Annualised factor consumption (International Unit [IU]) (prophylactic treatment) | Assessed by diary | 24 months | |
| Primary | Amount of factor Product used to treat a bleed (on-demand treatment) | Assessed by diary | 24 months | |
| Primary | Number of injections to treat a bleed (on-demand treatment) | Assessed by diary | 24 months |
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