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Weekly shot aims to get severe hemophilia patients moving more

NCT ID NCT05817812

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 02, 2026 · Updated 1 time

Summary

This study is testing a new medicine called efanesoctocog alfa in about 90 people aged 12 and older with severe hemophilia A. Participants receive a weekly injection for 24 months to see if it helps them be more physically active and improves joint health. The study uses activity trackers and diaries to track bleeds, pain, and quality of life.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

93 people

The number who actually took part.

Started

Jul 2023

Finished

Jun 2026

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

12 years and older

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.

Key Inclusion Criteria: * Previous treatment for haemophilia A with any marketed recombinant and/or plasma-derived FVIII for at least 150 EDs. * Having received prophylactic treatment with any marketed recombinant and/or plasma FVIII or emicizumab per local label for at least 12 months preceding enrolment. * Having 12 months documented pre-study treatment data regarding prophylactic treatment prescriptions and 6 months data on bleeding episodes prior to baseline visit. * Willingness and ability to complete training in the use of the study ePD and to use the ePD in their own smartphone throughout the study. * Willingness and ability to use the activity tracker provided by the sponsor to measure physical activity and heart rate. * Be able and willing to administer efanesoctocog alfa intravenously at home. Key Exclusion Criteria: * Serious musculoskeletal and/or neurological impairment limiting the mobility and the physical ability to a degree that makes the patient unsuitable for the study as judged by the investigator. * Other known coagulation disorder(s) in addition to haemophilia A. * History and/or current positive inhibitor test defined as ≥0.6 BU/mL. * Treatment with NSAIDs above the maximum dose specified in the prescribing information within 2 weeks prior to screening. * Systematic treatment within 12 weeks prior to screening with chemotherapy and/or other immunosuppressive drugs. * Treatment with an investigational product within 30 days or 5.5 half-lives prior to screening, whichever is longer. * Major surgery within 12 weeks prior to screening or planned major orthopaedic surgery to occur during the study. * At baseline visit, patients who have not been compliant in using the activity tracker.

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Conditions

The condition(s) this trial relates to.

blood coagulation disease coagulation protein disease hemophilia A severe hemophilia A

As listed by the trial registrant

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

Hemophilia A, severe

Contacts and locations

Locations

  • Investigational Site

    Vienna, Austria

  • Investigational Site

    Zagreb, Croatia

  • Investigational Site

    Brno, Czechia

  • Investigational Site

    Prague, Czechia

  • Investigational Site

    Bordeaux, France

  • Investigational Site

    Le Kremlin-Bicêtre, France

  • Investigational Site

    Marseille, France

  • Investigational Site

    Strasbourg, France

  • Investigational Site

    Berlin, Germany

  • Investigational Site

    Frankfurt, Germany

  • Investigational Site

    Giessen, Germany

  • Investigational Site

    Hamburg, Germany

  • Investigational Site

    Athens, Greece

  • Investigational Site

    Dublin, Ireland

  • Investigational Site

    Catanzaro, Italy

  • Investigational Site

    Florence, Italy

  • Investigational Site

    Naples, Italy

  • Investigational Site

    Parma, Italy

  • Investigational Site

    Rome, Italy

  • Investigational Site

    Utrecht, Netherlands

  • Investigational Site

    Oslo, Norway

  • Investigational Site

    Ljubljana, Slovenia

  • Investigational Site

    Barcelona, Spain

  • Investigational Site

    Madrid, Spain

  • Investigational Site

    Oviedo, Spain

  • Investigational Site

    Lund, Sweden

  • Investigational Site

    Solna, Sweden

  • Investigational Site

    Canterbury, United Kingdom

  • Investigational Site

    Newcastle upon Tyne, United Kingdom

  • Investigational Site

    Oxford, United Kingdom

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