Hemophilia BB-MORENCT03901755
An International Study to Evaluate the Real-world Effectiveness and Usage of Alprolix in Patients With Haemophilia B
An observational study of Hemophilia B, run by Swedish Orphan Biovitrum at 29 sites in 9 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hemophilia B
- What is being tested?
- Alprolix
- How many people
- 151 participants
- Where
- 29 sitesin 9 countries
- Study dates
- 12 Sep 2019to 12 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All eligible patients who present for a routine Clinical visit will be asked to participate in the study by the treating physician at participating haemophilia treatment centres.
Who may be able to join
- 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.
Who cannot join
- Participation in an investigational medicinal product trial at enrolment visit
Trial locations and contacts
29 sites in 9 countries.
29 sites in 9 countries
United Kingdom7 sites
Swedish Orphan Biovitrum Research Site
Hull
Swedish Orphan Biovitrum Research Site
London, NW3 2QG
Swedish Orphan Biovitrum Research Site
London, SE1 7EH
Swedish Orphan Biovitrum Research Site
London, W12 0HS
Swedish Orphan Biovitrum Research Site
London, WC1N 3JH
Swedish Orphan Biovitrum Research Site
Manchester
Swedish Orphan Biovitrum Research Site
Oxford
Italy6 sites
Swedish Orphan Biovitrum Research Site
Bari
Swedish Orphan Biovitrum Research Site
Florence
Swedish Orphan Biovitrum Research Site
Genova
Swedish Orphan Biovitrum Research Site
Milan
Swedish Orphan Biovitrum Research Site
Roma
Swedish Orphan Biovitrum Research Site
Turin
Spain4 sites
Swedish Orphan Biovitrum Research Site (Hospital de Vall d'Hebrón)
Barcelona
Swedish Orphan Biovitrum Research Site (Hospital Sant Joan de Deu)
Barcelona
Swedish Orphan Biovitrum Research Site
Murcia
Swedish Orphan Biovitrum Research Site
Vigo
Sweden4 sites
Swedish Orphan Biovitrum Research Site
Gothenburg
Swedish Orphan Biovitrum Research Site
Malmö
Swedish Orphan Biovitrum Research Site (Karolinska University Hospital adult)
Stockholm
Swedish Orphan Biovitrum Research Site (Karolinska University Hospital pediatric)
Stockholm
Czechia2 sites
Swedish Orphan Biovitrum Research Site
Brno
Swedish Orphan Biovitrum Research Site
Prague
Greece2 sites
Swedish Orphan Biovitrum Research Site (Haemophilia Center Aghia Sophia Children's Hospital)
Athens
Swedish Orphan Biovitrum Research Site (Laikο General Hospital of Athens)
Athens
Saudi Arabia2 sites
Swedish Orphan Biovitrum Research Site (King Faisal Hospital adult)
Riyadh
Swedish Orphan Biovitrum Research Site (King Faisal Hospital pediatric)
Riyadh
About this study
Official 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
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.
- Conditions
- Hemophilia B
- Being tested
- Alprolix
- Keywords
- Blood Coagulation Disorder, Hematologic Diseases, Coagulation Protein Disorder, Hemorrhagic Disorder, Genetic Diseases, Inborn
- Medical subject headings
- Hemophilia B, Blood Coagulation Disorders, Hematologic Diseases, Coagulation Protein Disorders, Hemorrhagic Disorders, Genetic Diseases, Inborn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlprolixDrug
Also called Eftrenonacog alfa, rFIXFc
Extended half-life factor IX product
| Study group | Role | What they receive |
|---|---|---|
| Prophylactic patients | Alprolix will be prescribed according to local practice and administered by patients with haemophilia B for prophylactic treatment Receives: Drug: Alprolix | |
| On demand patients | Alprolix will be prescribed according to local practice and administered by patients with haemophilia B for on-demand treatment Receives: Drug: Alprolix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Annualised bleeding rate (ABR)
Bleeding episodes assessed according to local practice
Measured: 24 months
Annualised injection frequency
Assessed by prescription
Measured: 24 months
Annualised factor consumption
Assessed by dispensed factor product
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2019
- Study start12 Sep 2019
- Primary completion12 Mar 2024
- Study completion12 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemophilia BStudies of the same condition, open and under way.
- More trials run by Swedish Orphan BiovitrumThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swedish Orphan Biovitrum
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elena Santagostino, MD, Study director, Swedish Orphan Biovitrum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03901755
- Sponsor's protocol ID
- Sobi.Alprolix-002
- Acronym
- B-MORE
- Status last verified
- Sep 2025
- First submitted
- 2 Apr 2019
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT03901755
- Acronym / sponsor ID
- B-MORE / Sobi.Alprolix-002
- Conditions
- Hemophilia B
- Keywords
- Blood Coagulation Disorder, Hematologic Diseases, Coagulation Protein Disorder, Hemorrhagic Disorder, Genetic Diseases, Inborn
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Swedish Orphan BiovitrumIndustry (pharma, biotech, devices)
- Study start
- 12 Sep 2019 (actual)
- Primary completion
- 12 Mar 2024 (actual)
- Study completion
- 12 Mar 2024 (actual)
- First posted
- 3 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prophylactic patients | – | Drug: AlprolixAlprolix will be prescribed according to local practice and administered by patients with haemophilia B for prophylactic treatment |
| On demand patients | – | Drug: AlprolixAlprolix will be prescribed according to local practice and administered by patients with haemophilia B for on-demand treatment |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All eligible patients who present for a routine Clinical visit will be asked to participate in the study by the treating physician at participating haemophilia treatment centres.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Participation in an investigational medicinal product trial at enrolment visit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlprolixAlso: Eftrenonacog alfa, rFIXFcExtended half-life factor IX product | Drug | On demand patients, Prophylactic patients |
Primary outcome
Annualised bleeding rate (ABR)
Time frame: 24 months
Bleeding episodes assessed according to local practice
Annualised injection frequency
Time frame: 24 months
Assessed by prescription
Annualised factor consumption
Time frame: 24 months
Assessed by dispensed factor product
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Hemophilia B
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Hemophilia B
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elena Santagostino, MD study director
Swedish Orphan Biovitrum
29 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemophilia B, run by Swedish Orphan Biovitrum at 29 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United Kingdom, Italy, Spain, Sweden, Czechia and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Annualised bleeding rate (ABR) (time frame: 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2025.