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Can a Once-Weekly shot cut the burden of hemophilia a?

NCT ID NCT07830693

NEW Knowledge-focused Sponsor: Nantes University Hospital 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 21, 2026 · Last updated Sep 21, 2026

Summary

Researchers are studying how switching to efanesoctocog alfa (ALTUVOCT), a long-acting factor VIII therapy given once a week, affects adults and children with severe or moderate hemophilia A in routine care. The study tracks factor use, treatment satisfaction, and quality of life before and after the switch using questionnaires and interviews. It aims to understand why patients and doctors choose to switch and what changes in real-world practice.

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 long-acting factor VIII replacement therapy given once weekly
What this could lead to
If the switch works well in routine care, it could mean fewer infusions and better quality of life for people with hemophilia A, and it could help doctors and health systems plan treatment more effectively.
What could go wrong
This study observes patients who switch treatments rather than randomly assigning them, so differences may reflect who chose to switch rather than the drug itself. It also relies on questionnaires, which can be subjective, and it does not test the drug against other options head-to-head.

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

About 553 people

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

Expected to start

Jan 2027

An estimate. Start dates often move.

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Who is studied

The study population targets people with severe hemophilia A or moderate hemophilia A (FVIII:C \< 3 IU/dL), without inhibitors / with history of inhibitors, of any sex, any age. These subjects must be followed in one centre of the BERHLINGO network. The patients will be included in the flow, with routine consultations.

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: * Conduct of research: patients followed up at one of the eight investigator centers of the BERHLINGO network * Pathology: severe HA (FVIII:C \<1 IU/dL) or moderate HA (1 IU/dL \< FVIII:C \< 3 IU/dL), without inhibitor / with history of inhibitor (inhibitor rate \< 0.6 Bethesda unit per milliliter (BU/mL)) * Prophylactic Treatment with FVIII or emicizumab since at least March 1, 2025 - * Sex: male or female * Age: patients of all age * Consent: patient who did not object to their participation in the E-PROTECT study Exclusion Criteria: * Patients under guardianship

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Conditions

The condition(s) this trial relates to.

hemophilia A severe hemophilia A

As listed by the trial registrant

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

Hemophilia A patient

How to take part

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

  1. The places running it

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

  2. 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 ↗

  3. 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

Locations

  • Brest University Hospital

    Brest, 29609, France

  • CH Le Mans

    Le Mans, 72037, France

  • CHRU de Tours (Hôpital Trousseau)

    Chambray-lès-Tours, 37170, France

  • CHU Angers

    Angers, 49933, France

  • CHU de Bordeaux (Hôpital Pellegrin)

    Bordeaux, 33076, France

  • CHU de Caen

    Caen, 14033, France

  • CHU de Nantes

    Nantes, France

  • Rennes University Hospital

    Rennes, 35033, France

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