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New study tracks Real-World impact of hemophilia drug on joint health

NCT ID NCT06940830

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 01, 2026 · Updated 2 times

Summary

This study follows 250 people with hemophilia A who are taking efanesoctocog alfa to prevent bleeding. Researchers want to see how well it protects joints from bleeds over time in everyday life. Participants will be observed for several years to track bleeding rates and treatment needs.

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.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 250 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

Dec 2028

An estimate. End dates often move.

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.

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: 1. Male or female patient with a diagnosis of haemophilia A. 2. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. 3. Prescribed with efanesoctocog alfa prophylactic treatment within 6 months prior to study enrolment or at the latest at the enrolment visit, in accordance with local regulations. 4. Must have received prophylactic treatment(s) with any haemophilia product(s) for at least 12 months prior to being prescribed with efanesoctocog alfa treatment. 5. Have documented pre-study treatment data on haemophilia prophylaxis prescriptions and on treated bleeding episodes from the 12-months prior to being prescribed efanesoctocog alfa treatment and until enrolment into this study. 6. Willing to adhere to the visit schedule and to undergo mandatory study assessment (HJHS, PROs). 7. Willingness and the ability of the patient or their legally designated representative to document all bleeding episodes, including any treatments for those episodes. 8. For HEAD-US subgroup: Accept to undergo annual ultrasound assessment on the index joints (ankles, elbows, knees). Exclusion Criteria: 1. Acquired haemophilia A and other blood clotting disorders than hereditary haemophilia A. 2. Any positive FVIII inhibitor result (defined as inhibitor titre ≥0.6 Bethesda unit \[BU\]/mL) from the medical records in connection to the switch to efanesoctocog alfa until the enrolment visit. 3. Enrolment in a concurrent clinical interventional study, or intake of an investigational medicinal product (IMP), including for haemophilia prophylaxis, within 3 months prior to enrolment in this study. 4. Patient not suitable for participation, whatever the reason, as judged by the Investigator, e.g., patient is not able or willing to perform the study assessments.

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Conditions

The condition(s) this trial relates to.

blood coagulation disease coagulation protein disease hemophilia A

As listed by the trial registrant

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

Hemophilia A

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    29 sites in 8 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Sobi Investigational Site

    RECRUITING

    Zagreb, Croatia

  • Sobi Investigational Site

    RECRUITING

    Brno, Czechia

  • Sobi Investigational Site

    RECRUITING

    Ostrava, Czechia

  • Sobi Investigational Site

    RECRUITING

    Prague, Czechia

  • Sobi Investigational Site

    RECRUITING

    Bordeaux, France

  • Sobi Investigational Site

    RECRUITING

    Marseille, France

  • Sobi Investigational Site

    RECRUITING

    Montpellier, France

  • Sobi Investigational Site

    RECRUITING

    Nantes, France

  • Sobi Investigational Site

    RECRUITING

    Paris, France

  • Sobi Investigational Site

    RECRUITING

    Rennes, France

  • Sobi Investigational Site

    RECRUITING

    Rouen, France

  • Sobi Investigational Site

    RECRUITING

    Berlin, Germany

  • Sobi Investigational Site

    RECRUITING

    Bonn, Germany

  • Sobi Investigational Site

    RECRUITING

    Frankfurt am Main, Germany

  • Sobi Investigational Site

    RECRUITING

    Hamburg, Germany

  • Sobi Investigational Site

    RECRUITING

    Munich, Germany

  • Sobi Investigational Site

    RECRUITING

    Dublin, Ireland

  • Sobi Investigational Site

    RECRUITING

    Catania, Italy

  • Sobi Investigational Site

    RECRUITING

    Padua, Italy

  • Sobi Investigational Site

    RECRUITING

    Turin, Italy

  • Sobi Investigational Site

    RECRUITING

    A Coruña, Spain

  • Sobi Investigational Site

    RECRUITING

    Barcelona, Spain

  • Sobi Investigational Site

    RECRUITING

    Málaga, Spain

  • Sobi Investigational Site

    RECRUITING

    Palma de Mallorca, Spain

  • Sobi Investigational Site

    RECRUITING

    Zaragoza, Spain

  • Sobi Investigational Site

    RECRUITING

    Birmingham, United Kingdom

  • Sobi Investigational Site

    RECRUITING

    Cardiff, United Kingdom

  • Sobi Investigational Site

    RECRUITING

    London, United Kingdom

  • Sobi Investigational Site

    RECRUITING

    Manchester, United Kingdom

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