Haemophilia A Clinical Trial
— PREVENTOfficial title:
A 24-month Prospective, Non-interventional, Multicentre Study to Evaluate the Real-World Usage and Effectiveness of Elocta and Alprolix in Patients With Haemophilia A or B
| NCT number | NCT03055611 |
| Other study ID # | Sobi.HAEM89-002 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | May 9, 2017 |
| Est. completion date | April 19, 2022 |
| Verified date | May 2022 |
| Source | Swedish Orphan Biovitrum |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
Elocta (rFVIIIFc) and Alprolix (rFIXFc) are recombinant extended half-life coagulation factor products. The purpose of this non-interventional study is to describe the real-world usage and effectiveness of Elocta and Alprolix in the prophylactic treatment of haemophilia A and B.
| Status | Completed |
| Enrollment | 201 |
| Est. completion date | April 19, 2022 |
| Est. primary completion date | April 19, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility | Inclusion Criteria: - Have a diagnosis of haemophilia A or B and previously treated with factor Product - Have started prophylactic Elocta/Alprolix treatment prior to enrollment visit, or at enrollment prescribed prophylactic treatment with Elocta or 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, from four weeks prior to first injection with Elocta or Alprolix to enrollment visit. |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Swedish Orphan Biovitrum Reserach site | Berlin | |
| Germany | Swedish Orphan Biovitrum Reserach Site | Blaubeuren | |
| Germany | Swedish Orphan Biovitrum Research Site | Bonn | |
| Germany | Swedish Orphan Biovitrum Research Site | Delmenhorst | |
| Germany | Swedish Orphan Biovitrum Research Site | Duisburg | |
| Germany | Swedish Orphan Biovitrum Reserach site | Erlangen | |
| Germany | Swedish Orphan Biovitrum Research Site | Frankfurt | |
| Germany | Swedish Orphan Biovitrum Reserach site | Frankfurt | |
| Germany | Swedish Orphan Biovitrum Research Site | Fürth | |
| Germany | Swedish Orphan Biovitrum Research Site | Hamburg | |
| Germany | Swedish Orphan Biovitrum Research Site | Hannover | |
| Germany | Swedish Orphan Biovitrum Reserach site | Hannover | |
| Germany | Swedish Orphan Biovitrum Reserach site | Heidelberg | |
| Germany | Swedish Orphan Biovitrum Reserach site | Homburg | |
| Germany | Swedish Orphan Biovitrum Research Site | Jena | |
| Germany | Swedish Orphan Biovitrum Reserach Site | Jena | |
| Germany | Swedish Orphan Biovitrum Reserach site | Leipzig | |
| Germany | Swedish Orphan Biovitrum Reserach Site | Mörfelden-Walldorf | |
| Germany | Swedish Orphan Biovitrum Research Site | München | |
| Germany | Swedish Orphan Biovitrum Reserach site | München | |
| Germany | Swedish Orphan Biovitrum Reserach site | Münster | |
| Germany | Swedish Orphan Biovitrum Research Site | Würzburg |
| Lead Sponsor | Collaborator |
|---|---|
| Swedish Orphan Biovitrum |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Annualised bleeding rate (ABR) | Based on bleeding episodes assessed by local practice | 24 months | |
| Primary | Annualised injection frequency | Assessed by prescription | 24 months | |
| Primary | Annualised factor consumption (IU) | Assessed by dispensed factor product | 24 months |
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