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New study tests clotting drug for safer surgery in women with hemophilia a

NCT ID NCT05936580

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 is testing a drug called Nuwiq, a lab-made clotting factor, to prevent excessive bleeding during major surgery in women and girls with hemophilia A. About 28 participants will receive Nuwiq around the time of their surgery. Researchers will check if the drug successfully controls bleeding during and after the operation.

What this could mean

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

Active substance
Nuwiq (a lab-made clotting factor VIII)
What this could lead to
If successful, this could confirm that Nuwiq is a safe and effective option to control bleeding during surgery for women and girls with hemophilia A.
What could go wrong
This is a small, single-group study with only 28 participants, so results may not apply to everyone. As a phase 4 trial, it is confirmatory, but unexpected side effects or lack of efficacy are still possible.

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.

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Feb 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

12 years and older

Sex

Female 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: 1. Women/girls with haemophilia A (FVIII:C ≥1-\<40%) according to medical history. Additionally, women/girls with documented FVIII activity levels between ≥ 40% and 50% may be included if there is a documented history of clinically significant bleeding episodes consistent with haemophilia A; and/or either documented prior treatment with FVIII concentrates or a clinical indication that FVIII treatment would have been appropriate (e.g., use of FVIII from a family member, or treatment with alternative haemostatic agents due to access limitations) 2. At least 12 years of age 3. Scheduled to undergo major surgery\* requiring FVIII treatment, including elective and emergency procedures and caesarean section in pregnant women with haemophilia A 4. Freely given written informed consent of the patient, or parent/legal representative where applicable, obtained in accordance with local regulations Exclusion Criteria: 1. Coagulation disorder other than haemophilia A 2. Present or past FVIII inhibitor (≥0.6 Bethesda units \[BU\]/mL) 3. 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) 4. Known hypersensitivity to Nuwiq's active substance or its excipients (sucrose, sodium chloride, calcium chloride dihydrate, arginine hydrochloride, sodium citrate dihydrate, poloxamer 188) 5. Pregnancy, except in participants with a planned caesarean section 6. Already had surgery in this study 7. Current participation in another interventional clinical trial 8. 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

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 places running it

    16 sites in 10 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

  • Avenue de la République

    RECRUITING

    Chambray-lès-Tours, France

  • Aziendo Ospedaliera "Puglieze Ciaccio"

    RECRUITING

    Catanzaro, Italy

  • CHU de Nantes Hôtel-Dieu

    RECRUITING

    Nantes, France

  • Centro Hospitalario Pereira Rossell

    NOT_YET_RECRUITING

    Montevideo, Uruguay

  • Chu de Strasbourg

    NOT_YET_RECRUITING

    Stasbourg, France

  • Clinical Center for Serbia

    RECRUITING

    Belgrade, Serbia

  • Gerinnungszentrum Rhein-Ruhr

    RECRUITING

    Duisburg, Germany

  • Helsinki University Hospital,Coagulation Disorder Unit

    RECRUITING

    Helsinki, Finland

  • Hospital Universitario Virgen del Rocio

    RECRUITING

    Seville, Spain

  • Hospital Universitario la Paz

    RECRUITING

    Madrid, Spain

  • Insel Spital Bern

    NOT_YET_RECRUITING

    Bern, Switzerland

  • Policlinico "P. Giaconne"

    RECRUITING

    Palermo, Italy

  • St. James's University Hospital

    RECRUITING

    Leeds, United Kingdom

  • UT Health San Antonio

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Universitätsklinikum Bonn,Institut für Experimentelle Haematologie und Transfusionsmedizin

    RECRUITING

    Bonn, Germany

  • Universitätsklinikum Hamburg Eppendorf,II. Medizinische Klinik und Poliklinik

    RECRUITING

    Hamburg, Germany

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