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Can a lab-made antibody stop bleeding in a rare blood disorder?

NCT ID NCT07830732

NEW Disease control Sponsor: Novo Nordisk A/S Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 testing denecimig, an experimental antibody given as an injection under the skin, in adults newly diagnosed with acquired haemophilia A. This rare condition causes the immune system to attack a clotting protein, leading to sudden and sometimes severe bleeding. The Phase 3 trial follows about 84 participants for roughly a year and a half to see whether denecimig reduces treated bleeding episodes and cuts the need for standard clotting-factor or bypassing-agent infusions. Because the study is open-label, everyone involved knows who receives the drug.

What this could mean

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

Active substance
denecimig, an experimental antibody therapy given by injection under the skin
What this could lead to
If it works, denecimig could offer adults with acquired haemophilia A a preventive treatment that lowers bleeding episodes and reduces reliance on frequent factor or bypassing-agent infusions.
What could go wrong
The trial is open-label, so researchers and participants know who gets the drug, which can bias how bleeding episodes are reported. Acquired haemophilia A is rare, and results from 84 adults may not apply to children, older adults with other conditions, or people whose inhibitor levels differ.

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 84 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Mar 2029

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

18 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: * Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study. * Male or female participants (sex assigned at birth, inclusive of all gender identities) newly diagnosed with acquired haemophilia A (AHA) prior to signing the informed consent form, with AHA diagnosis (FVIII activity lesser than (\<) 50 percentage (%) and FVIII inhibitors greater than (\>) 0.6 Bethesda units \[BU\]) confirmed at screening. * Treatment-requiring bleed(s) due to AHA from diagnosis and until screening. * The participant is capable of following study procedures and able to seek medical attention when needed. Exclusion Criteria: * Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate and highly effective contraceptive method. * Previous or current thromboembolic disease or eventsa (with the exception of previous catheter associated thrombosis for which anti-thrombotic treatment is not currently ongoing) or risk of thromboembolic disease. * Life expectancy \<3 months at the time of screening, as evaluated by the investigator. * Therapy with immunosuppressive or immune modulating drugs for treatment of AHA (other than less than or equal to (≤) 2 days of prednisolone (or equivalent) for AHA at a dose ≤100 mg per day) prior to screening. * Immunosuppressive therapy (IST) initiated prior to AHA diagnosis for other medical conditions (e.g., other autoimmune disorders) is permitted, provided it was initiated greater than or equal to (≥) 6 months prior to screening, has been maintained at a stable dose and regimen since initiation, and is expected to remain at a stable dose and regimen at least during the main treatment period (Weeks 0-12).

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Conditions

The condition(s) this trial relates to.

acquired hemophilia A hemophilia A

As listed by the trial registrant

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

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

    83 sites in 18 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: •••••@•••••

Locations

  • AOU Federico II Di Napoli - Dipartimento di Medicina Clinica e Chirurgia

    Naples, Campania, 80131, Italy

  • All India Institute of Medical Sciences (AIIMS)

    New Delhi, National Capital Territory of Delhi, 110029, India

  • Ankara Bilkent Şehir Hastanesi

    Ankara, 06800, Turkey (Türkiye)

  • Azienda Ospedaliera di Padova - UOSD Malattie Trombotiche ed Emorragiche

    Padova, 35128, Italy

  • Azienda Ospedaliero Universitaria Careggi - Centro malattie emorragiche e della coagulazione

    Florence, 50134, Italy

  • CHU DE NANTES-HOPITAL HOTEL-DIEU_Centre régional de traitement de l'Hémophilie

    Nantes, 44093, France

  • Centro Emofilia E Trombosi Angelo B Bonomi - Dep. Medicina Generale - Emostasi e Trombosi

    Milan, 20122, Italy

  • Charlotte Maxeke Johannesburg Academic Hospital

    Parktown, Johannesburg, Gauteng, 2193, South Africa

  • Duke University_Durham

    Durham, North Carolina, 27710, United States

  • Ege Üniversitesi Hastanesi- Hematoloji

    Izmir, 35100, Turkey (Türkiye)

  • Gauhati Medical College and Hospital

    Guwahati, Assam, 781032, India

  • Government Medical College, Kozhikode

    Kozhikode, Kerala, 673008, India

  • Gunma University Hospital_Hematology

    Maebashi-shi, Gunma, 371-8511, Japan

  • HCL - HOPITAL LOUIS PRADEL - Unité d'hémostase Clinique

    Bron, 69500, France

  • HOPITAL DE BICETRE_Centre de l'Hémophilie

    Le Kremlin-Bicêtre, 94270, France

  • Hemocentro UNICAMP

    Distrito de Barão Geraldo - Campinas, São Paulo, 13083-878, Brazil

  • Hemorio-Fundarj

    Rio de Janeiro, 20211-030, Brazil

  • Hippokration Hospital - Department of Hematology, Transfusion and Hemophilia Center

    Athens, 115 27, Greece

  • Hospital Ampang

    Ampang, Selangor, 68000, Malaysia

  • Hospital La Fe_Hemostasia y Trombosis

    Valencia, 46026, Spain

  • Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich

    Buenos Aires, 1426, Argentina

  • Hospital Queen Elizabeth 1

    Kota Kinabalu, Sabah, 88586, Malaysia

  • Hospital Samaritano Higienópolis - Instituto de Conhecimento Ensino e Pesquisa (ICEP)

    São Paulo, 01229-001, Brazil

  • Hospital Universitario La Paz

    Madrid, 28046, Spain

  • Hospital Universitario Virgen del Rocío

    Seville, 41013, Spain

  • Hospital Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital Virgen de la Arrixaca - Hematología

    El Palmar, Murcia, 30120, Spain

  • Hospital das Clínicas da Faculdade de Medicina da USP

    São Paulo, São Paulo, 05403-000, Brazil

  • Hyogo Medical University Hospital_Hematology

    Nishinomiya-shi, Hyogo, 663-8501, Japan

  • IMS and SUM Hospital

    Bhubaneswar, Odisha, 751003, India

  • INSTITUT COEUR POUMON_Service d'hémostase et transfusion

    Lille, 59037, France

  • Instituto de Hematologia DR.Ruben Davoli

    Rosario, Santa Fe Province, S2000, Argentina

  • Instytut Hematologii i Transfuzjologii

    Warsaw, 02-776, Poland

  • Ippokratio General Hospital Of Thessaloniki - Hemophilia Centre of Northern Greece

    Thessaloniki, 546 42, Greece

  • Kansai Medical University Hospital_Hematology-Oncology

    Hirakata-shi, Osaka, 573-1191, Japan

  • Laiko General Hospital Of Athens - Blood Transfusion Service and National Reference Centre for Congenital Bleeding Disorders

    Athens, 115 27, Greece

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • McMaster University

    Hamilton, Ontario, L8N 3Z5, Canada

  • Medizinische Hochschule Hannover - Hämatologie, Hämostaseologie, Onkologie

    Hanover, 30625, Germany

  • NIZAM'S Institute of Medical Sciences

    Hyderabad, Telangana, 500082, India

  • Nara Medical University Hospital_Pediatrics

    Nara, 634-8522, Japan

  • Niigata Cancer Center Hospital_Department of Internal Medicine

    Niigata-shi, Niigata, 951-8566, Japan

  • Nuffield Orthopaedic Centre - Oxford Haemophilia and Thrombosis Centre

    Oxford, OX3 7HE, United Kingdom

  • Penn State MS Hershey Med Ctr

    Hershey, Pennsylvania, 17033-2360, United States

  • Queen Elizabeth Hospital, Birmingham - Haemophilia

    Birmingham, B15 2TH, United Kingdom

  • Royal Brisbane and Women's Hospital - Integrated Cancer Research (I-CARE)

    Herston, Queensland, 4029, Australia

  • Royal Free Hospital - Haemophilia

    London, NW3 2QG, United Kingdom

  • Royal Hallamshire Hospital

    Sheffield, S10 2JF, United Kingdom

  • Royal Prince Alfred Hospital - Department of Haematology

    Camperdown, New South Wales, 2050, Australia

  • Sarawak General Hospital

    Kuching, Sarawak, 93586, Malaysia

  • Servicio de Hematologia - Hospital Italiano

    Buenos Aires, C1199ABB, Argentina

  • Skejby Blodsygdomme, blødercentret

    Aarhus N, 8200, Denmark

  • St Pauls Hospital

    Vancouver, British Columbia, V6Z1Y6, Canada

  • St Thomas' Hospital - Haemostasis and Thrombosis Centre

    London, SE1 7EH, United Kingdom

  • St. Michael's Hospital

    Toronto, Ontario, M5B 1W8, Canada

  • The Alfred - Cancer Trials

    Melbourne, Victoria, 3004, Australia

  • Tokyo Medical Univ. Hospital_Laboratory Medicine

    Tokyo, 160-0023, Japan

  • Tulane University School of Medicine

    Metairie, Louisiana, 70001, United States

  • UT Health San Antonio

    San Antonio, Texas, 78229, United States

  • UT Southwestern

    Dallas, Texas, 75390, United States

  • Unidade de Pesquisa Clínica do Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo

    Ribeirão Preto, São Paulo, 14051-140, Brazil

  • Uniklinik Leipzig - Hämatologie, Zelltherapie, Hämostaseologie, Infektiologie

    Leipzig, 04103, Germany

  • Univ Texas HSC-Houston

    Houston, Texas, 77030, United States

  • Univ of Pennsylvania Hospital

    Philadelphia, Pennsylvania, 19104, United States

  • University Hospital of Wales - Haemophilia

    Cardiff, CF14 4XW, United Kingdom

  • University of Iowa_Iowa City

    Iowa City, Iowa, 52242, United States

  • University of Minnesota

    Minneapolis, Minnesota, 55455, United States

  • University of North Carolina

    Chapel Hill, North Carolina, 27614, United States

  • University of Oklahoma Health

    Oklahoma City, Oklahoma, 73104, United States

  • University of Utah Health

    Salt Lake City, Utah, 84106, United States

  • University of Vermont Med Ctr

    Burlington, Vermont, 05401, United States

  • University of Virginia

    Charlottesville, Virginia, 22903, United States

  • Universitätsklinikum Bonn - Institut für Experimentelle Hämatologie

    Bonn, 53127, Germany

  • Universitätsklinikum Regensburg - Innere Med. III

    Regensburg, 93053, Germany

  • Uniwersytecki Szpital Kliniczny W Poznaniu

    Poznan, 60-569, Poland

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-214, Poland

  • Victoria Hospital, Bangalore

    Bangalore, 560002, India

  • Virginia Cwealth Univ Richmond

    Richmond, Virginia, 23298, United States

  • Vivantes Netzwerk für Gesundheit GmbH - Vivantes Klinikum im Friedrichshain

    Berlin, 10249, Germany

  • Washington Ctr Bleed Disorder

    Seattle, Washington, 98195, United States

  • Washington University

    St Louis, Missouri, 63110, United States

  • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M.Kopernika w Lodzi

    Lodz, 93-513, Poland

  • İstanbul Üniversitesi Cerrahpaşa Tıp Fakültesi Hastanesi

    Istanbul, 34098, Turkey (Türkiye)

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