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New hope for hemophilia patients facing surgery: clotting factor trial underway

NCT ID NCT05935358

Disease control Sponsor: Octapharma 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests whether a recombinant factor VIII product called Nuwiq can safely prevent bleeding during major surgery in people with severe hemophilia A who are already on emicizumab. About 28 male patients aged 12 and older will take part. The main goal is to see if the treatment successfully controls bleeding during and after the operation.

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 28 people

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

Started

Nov 2023

Expected to finish

Sep 2026

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

12 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: * Severe haemophilia A (FVIII activity \[FVIII:C\] \<1%) according to medical history * Male patients at least 12 years of age * Previous treatment with any FVIII product(s) for at least 150 exposure days * On regular prophylaxis with emicizumab for at least 1 month prior to a scheduled major elective surgery requiring FVIII treatment * Freely given written informed consent of the patient, or parent/legal representative where applicable, obtained in accordance with local regulations Exclusion Criteria: * Coagulation disorder other than haemophilia A * Present or past FVIII inhibitor (≥0.6 Bethesda units \[BU\]/mL) according to medical history * Severe liver or kidney disease (alanine aminotransferase \[ALT\] and/or aspartate aminotransferase \[AST\] levels \>5 times the upper limit of normal; or creatinine \>120 μmol/L) * Known hypersensitivity to Nuwiq's active substance or its excipients (sucrose, sodium chloride, calcium chloride dihydrate, arginine hydrochloride, sodium citrate dihydrate, poloxamer 188) * Already had surgery in this study * Current participation in another interventional clinical trial * Treatment with any investigational medicinal product (IMP) within 30 days prior to screening visit

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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.

Severe hemophilia A

How to take part

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

  1. The places running it

    18 sites in 11 countries. 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

  • Azienda Ospedaliera Pugliese Ciaccio

    RECRUITING

    Catanzaro, Italy

  • Azienda Ospedaliero Universitaria Careggi - Centro Emofilia

    RECRUITING

    Florence, Italy

  • CHRU de Tours

    RECRUITING

    Tours, France

  • CHU de Nantes Hôtel-Dieu

    RECRUITING

    Nantes, France

  • Centre for Haemopilia, Institute for transfusion medicine of Republic of North Macedonia

    RECRUITING

    Skopje, North Macedonia

  • Centro Trombosi e Malattie Emorragiche, ITCCS Humanitas Research Hospital

    RECRUITING

    Milan, Italy

  • Christian Medical College Vellore

    RECRUITING

    Vellore, Tamil Nadu, India

  • Clinical Center for Serbia Belgrade

    RECRUITING

    Belgrade, Serbia

  • Gerinnungszentrum Rhein-Ruhr

    RECRUITING

    Duisburg, Germany

  • Helsinki University Hospital

    RECRUITING

    Helsinki, Finland

  • Hospital Universitario La Paz

    RECRUITING

    Madrid, Spain

  • Hospital Universitario Virgen del Rocio

    RECRUITING

    Seville, Spain

  • St. James's University Hospital

    NOT_YET_RECRUITING

    Leeds, United Kingdom

  • St. John's Medical College Hospital

    RECRUITING

    Bengaluru, India

  • UT Southwestern Medical Center

    RECRUITING

    Dallas, Texas, 75390, United States

  • University Hospital Centre Zagreb

    RECRUITING

    Zagreb, Croatia

  • Universitätsklinikum Hamburg Eppendorf (UKE)

    RECRUITING

    Hamburg, Germany

  • Vivantes Klinikum im Friedrichshein (KFH)

    RECRUITING

    Berlin, Germany

More trials for these conditions

Other studies related to the condition(s) this trial covers.