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New clotting factor offers continued bleeding control for hemophilia a patients

NCT ID NCT06716814

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study gives people with moderate or severe hemophilia A who finished a previous trial continued access to the drug efanesoctocog alfa. The drug is a lab-made clotting factor that helps prevent bleeding episodes. Researchers will monitor safety and how well it controls bleeding until the drug becomes commercially available or until March 2027.

What this could mean

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

Active substance
Efanesoctocog alfa (a lab-made clotting factor protein)
What this could lead to
If successful, this study will show that long-term use of efanesoctocog alfa is safe and effective at preventing bleeding episodes in people with hemophilia A.
What could go wrong
This is an open-label roll-over study, not a randomized trial, so results may be less definitive. Side effects or reduced effectiveness over time are possible, and the drug may not work for everyone.

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

About 104 people

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

Started

Mar 2025

Expected to finish

Mar 2027

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

6 years and older

Sex

Male participants only

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: * Capable of giving signed informed consent. Parents or legally designated representatives' consent is required for patients who are below 18 years of age or unable to give consent. Patients who are below 18 years of age may provide assent in addition to the parents'/legally designated representatives' consent, if appropriate. * Must have completed one of the required parent studies: Sobi.BIVV001-001, Sobi.BIVV001-003, LTS16294, or Sobi.BIVV001-004, and be receiving a clinical benefit from the efanesoctocog alfa treatment, as judged by the Investigator. * Willingness and ability of patient or their parent or legally designated representative to complete training in the use of the study patient diary and to complete the diary throughout the study. Exclusion Criteria: * Positive inhibitor result, defined as ≥0.6 Bethesda units (BU)/mL, present at the Baseline Visit. * Ongoing or planned participation in any interventional clinical study at the Baseline Visit. * Patient not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or patients potentially at risk of noncompliance to study procedures.

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Conditions

The condition(s) this trial relates to.

blood coagulation disease coagulation protein disease follicular lymphoma hemophilia A moderately severe hemophilia A severe hemophilia A

As listed by the trial registrant

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

Haemophilia A (moderate or severe) Severe haemophilia 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

    3 sites in 3 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: •••••@•••••

  • Contact

    Email: •••••@•••••

Locations

  • Sobi Investigational Site

    ACTIVE_NOT_RECRUITING

    Plovdiv, Bulgaria

  • Sobi Investigational Site

    ACTIVE_NOT_RECRUITING

    Sofia, Bulgaria

  • Sobi Investigational Site

    ACTIVE_NOT_RECRUITING

    Brest, France

  • Sobi Investigational Site

    ACTIVE_NOT_RECRUITING

    Bron, France

  • Sobi Investigational Site

    ACTIVE_NOT_RECRUITING

    Lille, France

  • Sobi Investigational Site

    WITHDRAWN

    Strasbourg, France

  • Sobi Investigational Site

    ACTIVE_NOT_RECRUITING

    Athens, Greece

  • Sobi Investigational Site

    ACTIVE_NOT_RECRUITING

    Catanzaro, Italy

  • Sobi Investigational Site

    ACTIVE_NOT_RECRUITING

    Florence, Italy

  • Sobi Investigational Site

    ACTIVE_NOT_RECRUITING

    Milan, Italy

  • Sobi Investigational Site

    RECRUITING

    Naples, Italy

  • Sobi Investigational Site

    ACTIVE_NOT_RECRUITING

    Parma, Italy

  • Sobi Investigational Site

    ACTIVE_NOT_RECRUITING

    Rome, Italy

  • Sobi Investigational Site

    ACTIVE_NOT_RECRUITING

    Rozzano, Italy

  • Sobi Investigational Site

    ACTIVE_NOT_RECRUITING

    Vicenza, Italy

  • Sobi Investigational Site

    RECRUITING

    Oslo, Norway

  • Sobi Investigational Site

    ACTIVE_NOT_RECRUITING

    A Coruña, Spain

  • Sobi Investigational Site

    ACTIVE_NOT_RECRUITING

    Zaragoza, Spain

  • Sobi Investigational Site

    ACTIVE_NOT_RECRUITING

    Gothenburg, Sweden

  • Sobi Investigational Site

    RECRUITING

    Lund, Sweden

  • Sobi Investigational Site

    ACTIVE_NOT_RECRUITING

    Stockholm, Sweden

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