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Real-World study tracks Alprolix's bleeding control in hemophilia b

NCT ID NCT03901755

Disease control Sponsor: Swedish Orphan Biovitrum Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study followed 151 people with hemophilia B who were already using or starting Alprolix, a long-lasting clotting factor. Over 24 months, researchers tracked how often bleeding occurred, how often the drug was injected, and how much was used. The goal was to see how well Alprolix works in real-world conditions, not just in controlled clinical trials.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Alprolix (a long-lasting clotting factor IX)
What this could lead to
If successful, this study could confirm that Alprolix effectively controls bleeding in real-world settings, supporting its use for managing hemophilia B.
What could go wrong
This is an observational study, not a controlled trial, so results may be influenced by patient differences. It does not test a new treatment, only describes current use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

151 people

The number who actually took part.

Started

Sep 2019

Finished

Mar 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * Participation in an investigational medicinal product trial at enrolment visit

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Conditions

The condition(s) this trial relates to.

blood coagulation disease coagulation protein disease hematologic disorder hemophilia B hemorrhagic disease hereditary disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hemophilia B

Contacts and locations

Locations

  • Swedish Orphan Biovitrum Research Site

    Brno, Czechia

  • Swedish Orphan Biovitrum Research Site

    Prague, Czechia

  • Swedish Orphan Biovitrum Research Site

    Dublin, Ireland

  • Swedish Orphan Biovitrum Research Site

    Bari, Italy

  • Swedish Orphan Biovitrum Research Site

    Florence, Italy

  • Swedish Orphan Biovitrum Research Site

    Genova, Italy

  • Swedish Orphan Biovitrum Research Site

    Milan, Italy

  • Swedish Orphan Biovitrum Research Site

    Roma, Italy

  • Swedish Orphan Biovitrum Research Site

    Turin, Italy

  • Swedish Orphan Biovitrum Research Site

    Oslo, Norway

  • Swedish Orphan Biovitrum Research Site

    Murcia, Spain

  • Swedish Orphan Biovitrum Research Site

    Vigo, Spain

  • Swedish Orphan Biovitrum Research Site

    Gothenburg, Sweden

  • Swedish Orphan Biovitrum Research Site

    Malmö, Sweden

  • Swedish Orphan Biovitrum Research Site

    Hull, United Kingdom

  • Swedish Orphan Biovitrum Research Site

    London, NW3 2QG, United Kingdom

  • Swedish Orphan Biovitrum Research Site

    London, SE1 7EH, United Kingdom

  • Swedish Orphan Biovitrum Research Site

    London, W12 0HS, United Kingdom

  • Swedish Orphan Biovitrum Research Site

    London, WC1N 3JH, United Kingdom

  • Swedish Orphan Biovitrum Research Site

    Manchester, United Kingdom

  • Swedish Orphan Biovitrum Research Site

    Oxford, United Kingdom

  • Swedish Orphan Biovitrum Research Site (Haemophilia Center Aghia Sophia Children's Hospital)

    Athens, Greece

  • Swedish Orphan Biovitrum Research Site (Hospital Sant Joan de Deu)

    Barcelona, Spain

  • Swedish Orphan Biovitrum Research Site (Hospital de Vall d'Hebrón)

    Barcelona, Spain

  • Swedish Orphan Biovitrum Research Site (Karolinska University Hospital adult)

    Stockholm, Sweden

  • Swedish Orphan Biovitrum Research Site (Karolinska University Hospital pediatric)

    Stockholm, Sweden

  • Swedish Orphan Biovitrum Research Site (King Faisal Hospital adult)

    Riyadh, Saudi Arabia

  • Swedish Orphan Biovitrum Research Site (King Faisal Hospital pediatric)

    Riyadh, Saudi Arabia

  • Swedish Orphan Biovitrum Research Site (Laikο General Hospital of Athens)

    Athens, Greece

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