NCT03901755Completed
An International Study to Evaluate the Real-world Effectiveness and Usage of Alprolix in Patients With Haemophilia B
A 24-month Prospective, Non-interventional, International, Multicentre Study to Describe the Real-world Effectiveness and Usage of Alprolix in Patients With Haemophilia B
Source: ClinicalTrials.gov · Last updated 29 Sept 2025
Brief summary (registry, in English)
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 (registry)
- Completed
- Study type
- Observational
- Enrollment
- 151 (actual)
- First submitted
- 2 Apr 2019
- Start date
- 12 Sept 2019
- Primary completion date
- 12 Mar 2024
- Lead sponsor
- Swedish Orphan Biovitrum
- Diseases
- Haemophilia
- NCT number
- NCT03901755
What you commit to
- Study type: Observational
- Participants enrolled: 151
- From 12 Sept 2019 to the primary completion date, 12 Mar 2024
- 26 sites in 9 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Participation in an investigational medicinal product trial at enrolment visit
Who the study is looking for
- 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 patients 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.
Sex: All · Does not accept healthy volunteers
Sites (26)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Brno | Czechia | Unknown status |
| - Coordinator of this site? Confirm its status | Prague | Czechia | Unknown status |
| Swedish Orphan Biovitrum Research Site (Hospital de Vall d'Hebrón) Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Swedish Orphan Biovitrum Research Site (Hospital Sant Joan de Deu) Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| - Coordinator of this site? Confirm its status | Murcia | Spain | Unknown status |
| - Coordinator of this site? Confirm its status | Vigo | Spain | Unknown status |
| - Coordinator of this site? Confirm its status | Hull | United Kingdom | Unknown status |
| - Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| - Coordinator of this site? Confirm its status | Manchester | United Kingdom | Unknown status |
| - Coordinator of this site? Confirm its status | Oxford | United Kingdom | Unknown status |
| Swedish Orphan Biovitrum Research Site (Haemophilia Center Aghia Sophia Children's Hospital) Coordinator of this site? Confirm its status | Athens | Greece | Unknown status |
| Swedish Orphan Biovitrum Research Site (Laikο General Hospital of Athens) Coordinator of this site? Confirm its status | Athens | Greece | Unknown status |
| - Coordinator of this site? Confirm its status | Dublin | Ireland | Unknown status |
| - Coordinator of this site? Confirm its status | Bari | Italy | Unknown status |
| - Coordinator of this site? Confirm its status | Florence | Italy | Unknown status |
| - Coordinator of this site? Confirm its status | Genova | Italy | Unknown status |
| - Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| - Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| - Coordinator of this site? Confirm its status | Turin | Italy | Unknown status |
| - Coordinator of this site? Confirm its status | Oslo | Norway | Unknown status |
| Swedish Orphan Biovitrum Research Site (King Faisal Hospital adult) Coordinator of this site? Confirm its status | Riyadh | Saudi Arabia | Unknown status |
| Swedish Orphan Biovitrum Research Site (King Faisal Hospital pediatric) Coordinator of this site? Confirm its status | Riyadh | Saudi Arabia | Unknown status |
| - Coordinator of this site? Confirm its status | Gothenburg | Sweden | Unknown status |
| - Coordinator of this site? Confirm its status | Malmö | Sweden | Unknown status |
| Swedish Orphan Biovitrum Research Site (Karolinska University Hospital adult) Coordinator of this site? Confirm its status | Stockholm | Sweden | Unknown status |
| Swedish Orphan Biovitrum Research Site (Karolinska University Hospital pediatric) Coordinator of this site? Confirm its status | Stockholm | Sweden | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.