Hemophilia A Clinical Trial
Official title:
24-month Prospective, Multicentre, Non-interventional Study to Evaluate the Effectiveness of Elocta Compared to Conventional Factor Products in the Prophylactic Treatment of Patients With Haemophilia A (A-SURE)
| Verified date | February 2023 |
| Source | Swedish Orphan Biovitrum |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
The purpose of the study is to evaluate the effectiveness of Elocta compared to conventional factor products in the prophylactic treatment of patients with haemophilia A over a 24-month prospective period. Data will also be collected for a 12 month retrospective period.
| Status | Completed |
| Enrollment | 361 |
| Est. completion date | November 3, 2021 |
| Est. primary completion date | November 3, 2021 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | N/A and older |
| Eligibility | Inclusion Criteria: - Male patients with a diagnosis of haemophilia A - Received prophylactic treatment with a factor product for management of haemophilia A in the 12 months prior to enrolment - At enrolment prescribed prophylactic treatment with Elocta or conventional factor product regardless of participation in the study - Having at least 12 months documented pre-study treatment data regarding prophylactic treatment prescriptions and bleeding episodes prior to the baseline visit - 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: - Enrolment in a concurrent clinical interventional study involving intake of an investigational medicinal product (IMP), within 1 year prior to enrolment - Previously treated with commercially available extended half-life products other than Elocta - Presence of factor VIII inhibitors (=0.60 Bethesda Unit [BU]/mL ) at the latest available inhibitor test using the Nijmegen modified Bethesda assay |
| Country | Name | City | State |
|---|---|---|---|
| Austria | Swedish Orphan Biovitrum Research site | Innsbruck | |
| Austria | Swedish Orphan Biovitrum Research site | Linz | |
| Austria | Swedish Orphan Biovitrum Research Site | St Polten | |
| Austria | Swedish Orphan Biovitrum Research site | Vienna | |
| Belgium | Swedish Orphan Biovitrum Research site | Brussel | |
| Finland | Swedish Orphan Biovitrum Research site | Helsinki | |
| France | Swedish Orphan Biovitrum Research site | Caen | |
| France | Swedish Orphan Biovitrum Research site | Montpellier | |
| France | Swedish Orphan Biovitrum Research site | Nancy | |
| France | Swedish Orphan Biovitrum Research site | Rennes | |
| Italy | Swedish Orphan Biovitrum Reserach site | Catanzaro | |
| Italy | Swedish Orphan Biovitrum Reserach site | Florence | |
| Italy | Swedish Orphan Biovitrum Research site | Milano | |
| Italy | Swedish Orphan Biovitrum Reserach site | Naples | |
| Italy | Swedish Orphan Biovitrum Research Site | Padova | |
| Italy | Swedish Orphan Biovitrum Reserach site | Palermo | |
| Italy | Swedish Orphan Biovitrum Reserach site | Parma | |
| Italy | Swedish Orphan Biovitrum Reserach site | Rome | |
| Italy | Swedish Orphan Biovitrum Research site | Turin | |
| Norway | Swedish Orphan Biovitrum Research site | Oslo | |
| Spain | Swedish Orphan Biovitrum research site | Alicante | |
| Spain | Swedish Orphan Biovitrum Reserach site | Barcelona | |
| Spain | Swedish Orphan Biovitrum Reserach site | Madrid | |
| Spain | Swedish Orphan Biovitrum Research site | Málaga | |
| Spain | Swedish Orphan Biovitrum Reserach site | Sevilla | |
| Spain | Swedish Orphan Biovitrum Research site | Valencia | |
| Sweden | Swedish Orphan Biovitrum Research site | Göteborg | |
| Sweden | Swedish Orphan Biovitrum Research site | Malmö | |
| Sweden | Swedish Orphan Biovitrum Research site | Stockholm | |
| United Kingdom | Swedish Orphan Biovitrum Research site | Birmingham | |
| United Kingdom | Swedish Orphan Biovitrum Research site | Canterbury | |
| United Kingdom | Swedish Orphan Biovitrum Research site | Liverpool | |
| United Kingdom | Swedish Orphan Biovitrum Reserach site | London | |
| United Kingdom | Swedish Orphan Biovitrum Research site | Manchester | |
| United Kingdom | Swedish Orphan Biovitrum Research site | Sheffield | |
| United Kingdom | Swedish Orphan Biovitrum Research site | Southampton |
| Lead Sponsor | Collaborator |
|---|---|
| Swedish Orphan Biovitrum | ICON plc |
Austria, Belgium, Finland, France, Italy, Norway, Spain, Sweden, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Annualised bleeding rate (ABR) | 24 months | ||
| Primary | Annualised injection frequency | 24 months | ||
| Primary | Annualised factor consumption (International Unit [IU]) | 24 months |
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