Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New shot could reduce bleeds in hemophilia a patients

NCT ID NCT07416526

Disease control Sponsor: Hoffmann-La Roche 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 10, 2026 · Updated 6 times

Summary

This Phase 3 trial tests a new drug called NXT007 (Zemocimig) against standard Factor VIII treatment to prevent bleeding in people with severe or moderate hemophilia A who do not have inhibitors. About 126 participants aged 12 and older will receive either NXT007 as a shot under the skin or their usual Factor VIII infusions. The main goal is to see if NXT007 reduces the number of bleeds that need treatment.

What this could mean

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

Active substance
NXT007 (Zemocimig)
What this could lead to
If successful, NXT007 could offer a more convenient, less frequent treatment option to prevent bleeding episodes in people with hemophilia A.
What could go wrong
This is a Phase 3 trial, but results may not apply to everyone. NXT007 is a new drug, and its long-term safety and effectiveness compared to standard care are still being studied.

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 126 people

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

Started

May 2026

Expected to finish

Sep 2031

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

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: * Diagnosis of severe (FVIII:C \<1 IU/dL \[International Unit per decilitre\]) or moderate (FVIII:C between ≥1 IU/dL and ≤5 IU/dL) congenital hemophilia A without inhibitors against FVIII * No documented inhibitor (i.e., \<0.6 BU/mL \[Bethesda unit per millilitre\]), FVIII half-life ≥6 hours, or FVIII recovery \>66% in the last 3 years prior to screening * Documented historical negative test for FVIII inhibitor (i.e., \<0.6 BU/mL) within 12 months prior to enrollment * Documentation of the details of prophylactic and episodic FVIII treatment and of the number and type of bleeding episodes for at least the last 6 months prior to screening * Agreement to adhere to the contraception requirements (for potential participants with childbearing potential) Exclusion Criteria: * Sensitivity to any of the study investigations, or components thereof, or drug or other allergy that, in the opinion of the investigator, contraindicates participation in the study * Use of systemic immunomodulators (e.g., interferon or rituximab) at the time of enrollment or planned use during the study, except for anti-retroviral therapy to treat HIV * Planned surgery (excluding minor procedures such as non-molar tooth extraction, incision and drainage) during the study * History or presence of an abnormal ECG that is deemed clinically significant, (e.g., complete left bundle branch block, second- or third- degree atrioventricular heart block) or ECG evidence or clinical history of prior myocardial infarction * Refusal to accept plasma-derived and/or blood product transfusion support in an emergency scenario * History of ventricular dysrhythmias or risk factors for ventricular dysrhythmias such as structural heart disease (e.g., severe left ventricular systolic dysfunction, left ventricular hypertrophy), coronary heart disease (symptomatic or with ischemia demonstrated by diagnostic testing)

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Hemophilia A are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

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.

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

    27 sites in 15 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

  • AP-HP - Hôpital Bicêtre

    RECRUITING

    Le Kremlin-Bicêtre, Val-de-Marne, 94270, France

  • Arbesu Hematologia

    RECRUITING

    Godoy Cruz, Mendoza Province, M5504FKD, Argentina

  • Azienda Ospedaliera Universitaria Careggi

    RECRUITING

    Florence, Tuscany, 50134, Italy

  • Chonnam National University Hwasun Hospital

    RECRUITING

    Hwasun-gun, 58128, South Korea

  • Eszak-Pesti Centrumkorhaz -Honvedkorhaz

    RECRUITING

    Budapest, Pest County, 1134, Hungary

  • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

    RECRUITING

    Milan, Lombardy, 20122, Italy

  • Groupement Hospitalier Est-Hopital Femme Mere enfant/Hospice civils de lyon

    RECRUITING

    Bron, 69500, France

  • Haemophilia Comprehensive Care Centre

    RECRUITING

    Parktown, Gauteng, 2193, South Africa

  • Hospital Das Clinicas da Faculdade de Medicina de Ribeirão Preto - USP - PPDS

    RECRUITING

    Ribeirão Preto, São Paulo, 14051-140, Brazil

  • Hospital Regional Universitario de Malaga ? Hospital General

    RECRUITING

    Málaga, 29010, Spain

  • Hospital Universitari i Politecnic La Fe de Valencia

    RECRUITING

    Valencia, 46026, Spain

  • Hospital Universitario La Paz - PPDS

    RECRUITING

    Madrid, 28046, Spain

  • Hospital Universitario Vall d'Hebron - PPDS

    RECRUITING

    Barcelona, 08035, Spain

  • Hospital Universitario Virgen del Rocio - PPDS

    RECRUITING

    Seville, 41013, Spain

  • IRCCS Istituto Clinico Humanitas

    RECRUITING

    Rozzano, Lombardy, 20089, Italy

  • Kyung Hee University Hospital at Gangdong

    RECRUITING

    Gangdong-gu, Seoul, 05278, South Korea

  • Nara Medical University Hospital

    RECRUITING

    Kashihara-shi, Nara, 634-8522, Japan

  • Rigshospitalet-Blegdamsvej 9

    RECRUITING

    Copenhaen, 2100, Denmark

  • Taichung Veterans General Hospital

    RECRUITING

    Taichung, 40705, Taiwan

  • The Royal London Hospital

    RECRUITING

    London, Middlesex, E1 1FR, United Kingdom

  • Tokyo Medical University Hospital

    RECRUITING

    Shinjuku-Ku, Tokyo, 160-0023, Japan

  • Tri-Service General Hospital

    RECRUITING

    Taipei, 11490, Taiwan

  • Universitair Medisch Centrum Utrecht

    RECRUITING

    Utrecht, 3584 CX, Netherlands

  • University Hospital of Wales

    RECRUITING

    Cardiff, CF14 4XW, United Kingdom

  • University of Colorado Hemophilia and Thrombosis Center

    RECRUITING

    Aurora, Colorado, 80045-7202, United States

  • University of Iowa Hospitals and Clinics

    RECRUITING

    Iowa City, Iowa, 52242-1009, United States

  • Universitätsklinikum Bonn

    RECRUITING

    Bonn, North Rhine-Westphalia, 53127, Germany

More trials for these conditions

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