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New shot could cut bleeding episodes for hemophilia a patients

NCT ID NCT05053139

Disease control Sponsor: Novo Nordisk A/S 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested a new medicine called Mim8 in 281 adults and teens with hemophilia A, including those whose bodies make antibodies that block standard treatment. Mim8 helps replace the missing clotting factor and is given as a weekly or monthly injection under the skin. The goal was to see if it prevents bleeding episodes better than current treatments. The study lasted about 12 to 29 months and tracked bleeds, side effects, and immune reactions.

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

281 people

The number who actually took part.

Started

Dec 2021

Finished

Dec 2024

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: 1. 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. 2. Male or female participants with diagnosis of congenital haemophilia A of any severity based on medical records. 3. Participant has been prescribed treatment with factor VIII concentrates or bypassing agent in the last 26 weeks prior to screening. 4. Age above or equal to 12 years at the time of signing informed consent. 5. Body weight greater than or equal to 30 kg. 6. Applicable to participants treated with on-demand/no prophylaxis prior to enrolment: ≥5 bleeds in the last 26 weeks prior to screening visit, for which factor VIII concentrates or bypassing agent has been prescribed. 7. Applicable to participants with FVIII activity ≥1% who are on prophylactic treatment: ≥1 bleed in the last 26 weeks prior to screening visit, for which factor VIII concentrates or bypassing agent has been prescribed. 8. Willingness and ability to comply with scheduled visits and study procedures, including the completion of diary and patient-reported outcomes questionnaires. Exclusion Criteria: 1. Previous participation in this study. Participation is defined as signed informed consent. 2. Participation (i.e., signed informed consent) in any interventional clinical study with receipt of the last dose within 6 months (or 5 half-lives of the investigational medicinal product, whichever is shorter) before planned randomisation. 3. Exposure to non-factor haemostatic products for bleeding prophylaxis within 6 months (or 5 half-lives of the medicinal product, whichever is shorter) before planned randomisation, for participants not included in the run-in. 4. Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method. Breast feeding is allowed only during the run-in period. 5. Any disorder, except for conditions associated with haemophilia A, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol. 6. Known or suspected hypersensitivity to trial product(s), any constituents of the product or to related products. 7. Receipt of gene therapy at any given time point. 8. Ongoing or planned immune tolerance induction (ITI) therapy. 9. Major surgery planned to take place after screening. 10. Known congenital or acquired coagulation disorders other than haemophilia A. 11. Hepatic dysfunction defined as aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) above 3 times the upper limit combined with total bilirubin above1.5 times the upper limit measured at screening. 12. Renal impairment defined as estimated Glomerular Filtration Rate (eGFR) below or equal to 30 ml/min/1.73 m\^2 for serum creatinine measured at screening. 13. Previous or current thromboembolic disease or events (with the exception of previous catheter-associated thrombosis for which anti-thrombotic treatment is not currently ongoing) or risk of thromboembolic disease, as evaluated by investigator. 14. Mental incapacity, unwillingness to cooperate, or a language barrier precluding adequate understanding and cooperation. 15. Other conditions (e.g., autoimmune disease) or laboratory abnormality that may increase risk of bleeding or thrombosis as evaluated by the investigator.

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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.

Haemophilia A Haemophilia A with inhibitors

Contacts and locations

Locations

  • AKH - Klin. Abt. f. Haematologie u. Haemostaseologie

    Vienna, 1090, Austria

  • Academisch Medisch Centrum

    Amsterdam, 1105 AZ, Netherlands

  • Acıbadem Adana Hastanesi-Hematoloji

    Adana, 01130, Turkey (Türkiye)

  • Akdeniz Universitesi

    Antalya, 01010, Turkey (Türkiye)

  • Akdeniz Üniversitesi Hastanesi- Hematoloji

    Antalya, Konyaaltı/ Antalya, 01010, Turkey (Türkiye)

  • Ap-Hp-Hopital Necker-1

    Paris, 75015, France

  • Ap-Hp-Hopital de Bicetre-1

    Le Kremlin-Bicêtre, 94275, France

  • Arizona H&T Phoenix Child Hosp

    Phoenix, Arizona, 85016-7710, United States

  • Arnold Palmer Hospital for Children

    Orlando, Florida, 32806, United States

  • Arthur Bloom Haemophilia Centre

    Cardiff, CF14 4XW, United Kingdom

  • Augusta University

    Augusta, Georgia, 30912, United States

  • Balad Hlth Sys-Welmont CardCVA

    Kingsport, Tennessee, 37660, United States

  • Beijing Children's Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100045, China

  • CHI Crumlin Haematology

    Dublin, D12 N512, Ireland

  • CMCV

    Ranipet, Tamil Nadu, 632517, India

  • Centre Hospitalier Universitaire de Bordeaux-Hopital Pellegrin

    Bordeaux, 33076, France

  • Centre Hospitalier Universitaire de Lille-Institut Coeur Poumon

    Lille, 59037, France

  • Centre Hospitalier Universitaire de Nantes-Hopital Hotel-Dieu

    Nantes, Nantes, France

  • Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou

    Rennes, 35033, France

  • Centro Hospitalar de São João_Porto

    Porto, 4200-319, Portugal

  • Centro Multidisciplinario Para El Desarrollo Especializado De La Investigación Clínica En Yucatán S.C.P. (CEMDEICY S.C.P.)

    Mérida, 97130, Mexico

  • Charlotte Maxeke Johannesburg Academic Hospital

    Parktown, Johannesburg, Gauteng, 2193, South Africa

  • Chengdu Women's and Children's Central Hospital

    Chengdu, Sichuan, 610074, China

  • Children HC Atlanta-Adv Pediat

    Atlanta, Georgia, 30329, United States

  • Children Oncohaematology department Children's Hospital,

    Vilnius, 08406, Lithuania

  • Children Regional Clinical Hospital

    Krasnodar, 350007, Russia

  • Children University Clinical Hospital

    Riga, 1004, Latvia

  • Children's Hosp-New Orleans

    New Orleans, Louisiana, 70118-5720, United States

  • Children's Hospital Los Angeles - Endocrinology

    Los Angeles, California, 90027, United States

  • Children's Hospital of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Children's Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310052, China

  • Children's Medical Center_Dallas

    Dallas, Texas, 75235, United States

  • Christian medical college

    Ludhiana, Punjab, 141008, India

  • Chung Shan Medical University Hospital

    Taichung, 402, Taiwan

  • Cincinnati Child's Hsp Med Ctr

    Cincinnati, Ohio, 45229, United States

  • City Clinical Hospital #4 (Dnipro) - Haematology centre

    Dnipro, 49102, Ukraine

  • City out-patient clinic 37, City Hemophilia Centre

    Saint Petersburg, 191186, Russia

  • Clinical Centre of Serbia, Institute for Haematology

    Belgrade, 11000, Serbia

  • Clinical Centre of Vojvodina

    Novi Sad, 21000, Serbia

  • Cliniques universitaires Saint-Luc - Service Hématologie

    Brussels, 1200, Belgium

  • Cure 4 the Kids Foundation

    Las Vegas, Nevada, 89135, United States

  • Daejeon Eulji Medical Center, Eulji University

    Daejeon, 35233, South Korea

  • Dayton Children Hemostati Ctr

    Dayton, Ohio, 45404, United States

  • Dipartimento di Ematologia Univ. Firenze

    Florence, 50134, Italy

  • Eastern Health Authority

    St. John's, Newfoundland and Labrador, A1B 3V6, Canada

  • Ege Universitesi Tip Fakultesi

    Bornova-IZMIR, 35100, Turkey (Türkiye)

  • Ege Üniversitesi Hastanesi- Hematoloji

    Bornova-IZMIR, 35100, Turkey (Türkiye)

  • Erasmus MC

    Rotterdam, 3015 GD, Netherlands

  • Gazi University

    Ankara, Beşevler/Ankara, 06500, Turkey (Türkiye)

  • Gazi Üniversitesi Hastanesi- Hematoloji

    Ankara, Beşevler/Ankara, 06500, Turkey (Türkiye)

  • HZRM Haemophilie-Zentrum Rhein Main GmbH

    Frankfurt am Main, 60596, Germany

  • Haemotology, Nanfang Hospital, Southern Medical University

    Guangzhou, Guangdong, 510515, China

  • Hemophilia Treatment Center

    Los Angeles, California, 90007, United States

  • Hopital Maisonneuve Rosemont

    Montreal, Quebec, HIT 2M4, Canada

  • Hospices Civils de Lyon- Hopital Louis Pradel-1

    Bron, 69500, France

  • Hospital Ampang

    Ampang, Selangor, 68000, Malaysia

  • Hospital Ampang

    Selangor Darul Ehsan, 68000, Malaysia

  • Hospital Queen Elizabeth 1

    Kota Kinabalu, Sabah, 88586, Malaysia

  • Hospital Regional Universitario de Málaga

    Málaga, 29009, Spain

  • Hospital Universitario La Paz

    Madrid, 28046, Spain

  • Hospital Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital of LUHS "Kauno Klinikos"

    Kaunas, LT-50161, Lithuania

  • Hospital of the University of Occupational And Environmental Health Japan, Pediatrics

    Kitakyusyu-shi, Fukuoka, 807 8555, Japan

  • Hôpital Cardiologique Louis Pradel

    Bron, 69500, France

  • IRCCS Humanitas Research Hospital - Centro Trombosi e Malattie Emorragiche

    Milan, 20089, Italy

  • Indiana Hemophilia-Thromb Ctr

    Indianapolis, Indiana, 46260, United States

  • Institut Oncologic "Prof. Dr. Ion Chiricuta" Cluj Napoca

    Cluj-Napoca, 400015, Romania

  • Institute of Hematology and Blood Diseases Hospital, Tianjin-Hematology

    Tianjin, Tianjin Municipality, 300020, China

  • Institute of blood pathology and transfusion medicine of NAMSU - General and haematol. surgery

    Lviv, 79044, Ukraine

  • Institutul Clinic Fundeni

    Bucharest, 022328, Romania

  • Istanbul University Oncology Institute

    Capa-ISTANBUL, Capa-ISTANBUL, 34093, Turkey (Türkiye)

  • Jichi Medical University Hospital_Hematology

    Tochigi, 329-0498, Japan

  • Jichi Medical University Hospital_Pediatrics

    Tochigi, 329-0498, Japan

  • Jinan Central Hospital

    Ji'Nan, Shandong, 250000, China

  • Jinan Central Hospital

    Jinan, Shandong, 250000, China

  • Kaohsiung Medical University Chung-Ho Memorial Hospital_Dept of Pediatrics

    Kaohsiung City, 807, Taiwan

  • King Faisal Specialist Hospital & Research Centre, Riyadh

    Riyadh, 12713, Saudi Arabia

  • Kyung Hee University Hospital at Gangdong

    Seoul, 05278, South Korea

  • London Health Sciences Center Ontario

    London, Ontario, N6A 5W9, Canada

  • McMaster University

    Hamilton, Ontario, L8N 3Z5, Canada

  • McMaster University Medical Center

    Hamilton, Ontario, L8N 3Z5, Canada

  • Memorial Health Univ Med Ctr

    Savannah, Georgia, 31404, United States

  • Michigan State University

    East Lansing, Michigan, 48823, United States

  • Morozovskaya municipal children hospital

    Moscow, 119049, Russia

  • Nagoya University Hospital_Blood Transfusion

    Aichi, 466-8560, Japan

  • Nanbu Medical Center & Children's Medical Center

    Okinawa, 901-1193, Japan

  • Nanfang Hospital, Southern Medical University-Haematology

    Guangzhou, Guangdong, 510515, China

  • National Center for Child Health and Development_Hematology

    Tokyo, 157-8535, Japan

  • National Medical Research institution of haemotology

    Moscow, 125167, Russia

  • National Taiwan University Hospital_Dept of Hematology

    Taipei, 100, Taiwan

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205, United States

  • Nemocnica sv. Cyrila a Metoda, UNB,Klinika hemat. a transfuz

    Bratislava, 851 07, Slovakia

  • Nirmal Hospital Pvt. Ltd.

    Surat, Gujarat, 395002, India

  • Ogikubo Hospital_Pediatries & Blood

    Tokyo, 167-0035, Japan

  • Oxford Haemophilia Comprehensive Care Center

    Oxford, OX3 7LJ, United Kingdom

  • Penn State MS Hershey Med Ctr

    Hershey, Pennsylvania, 17033-2360, United States

  • Post Graduate Institute of Child Health

    Noida, Uttar Pradesh, 201303, India

  • Providence Sacred Heart Medical Center & Children's Hospital

    Spokane, Washington, 99204, United States

  • Reg. State Budget Healthc. Inst. Regional Clinical Hospital

    Barnaul, 656024, Russia

  • Republican Hospital n.a. V. A. Baranov

    Petrozavodsk, 185019, Russia

  • Rigshospitalet - Department of Haematology, 2081

    København Ø, 2100, Denmark

  • Royal Free Haemophilia Comprehensive Care Centre

    London, NW3 2QG, United Kingdom

  • Royal University Hospital

    Saskatoon, Saskatchewan, S7N 0W8, Canada

  • Rush University Med. Cntr

    Chicago, Illinois, 60612, United States

  • SAHI Kuzbass Hospital(former Regional clinical hospital)

    Kemerovo, 650066, Russia

  • Saitama Children's Med Centre_Hematology-Oncology

    Saitama, 330-8777, Japan

  • Seth GS Medical College & KEM Hospital

    Mumbai, Maharashtra, 400012, India

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722, South Korea

  • Sheba MC - The Israeli National Hemophilia Center

    Tel Litwinsky, 52621, Israel

  • Shizuoka Children's Hospital, Hematology-Oncology

    Shizuoka, 420-8660, Japan

  • Spitalul Clinic Municipal Filantropia Craiova

    Craiova, Dolj, 200143, Romania

  • Spitalul Clinic Municipal de Urgenta Timisoara

    Timișoara, 300254, Romania

  • St Christopher Hosp for Child

    Philadelphia, Pennsylvania, 19134, United States

  • St James's CRF

    Dublin, Leinster, D08 A978, Ireland

  • St Joseph's Hospital Foundation

    Tampa, Florida, 33607, United States

  • St Thomas' Hospital - Haemostasis and Thrombosis Centre

    London, SE1 7EH, United Kingdom

  • St. John Regional Hospital

    Saint John, New Brunswick, E2L 4L4, Canada

  • St. Jude Clinic Novant Health

    Charlotte, North Carolina, 28204, United States

  • Stradini Clinic of Oncology

    Riga, 1002, Latvia

  • Szpital Uniwersytecki, Oddzial Kliniczny Hematologii

    Krakow, Lesser Poland Voivodeship, 30-688, Poland

  • Taichung Veterans General Hospital

    Taichung, 407, Taiwan

  • The Children's Hospital, Zhejiang University school of medicine

    Hangzhou, Zhejiang, 310052, China

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215006, China

  • The Hospital for Sick Children

    Toronto, Ontario, M5G 1X8, Canada

  • The Second Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan, 650101, China

  • Tokyo Medical Univ. Hospital_Laboratory Medicine

    Tokyo, 160-0023, Japan

  • Tongji Hospital, Tongji Medical College of HUST

    Wuhan, Hubei, 430030, China

  • Tongji Hospital, Tongji Medical College of HUST-Hematology

    Wuhan, Hubei, 430030, China

  • Torrence Hemby Ped Hem/Onc Ctr

    Charlotte, North Carolina, 28203, United States

  • ULS São João, E.P.E.

    Porto, 4200-319, Portugal

  • UMC Utrecht, Van Creveldkliniek

    Utrecht, 3584 CX, Netherlands

  • UZ Antwerpen - UZA - Kinderhemato-Oncologie

    Edegem, 2650, Belgium

  • UZ Leuven - Kindergeneeskunde

    Leuven, 3000, Belgium

  • Unidade Local de Saúde de Coimbra, E.P.E.

    Coimbra, 3000-561, Portugal

  • Unidade Local de Saúde de Santo António, E.P.E

    Porto, 4099-001, Portugal

  • Unilabs Slovensko, s. r. o.

    Košice, 04001, Slovakia

  • Univ Hosp Cleveland Med Ctr

    Cleveland, Ohio, 44106, United States

  • Univ TX Hlth Sci Ctr Houston

    Houston, Texas, 77030, United States

  • Univ of Colorado Sch of Med

    Aurora, Colorado, 80045, United States

  • Univ of Miami/SCCC

    Miami, Florida, 33136, United States

  • Univ of NE Med Center_Omaha

    Omaha, Nebraska, 68105, United States

  • University Of Iowa

    Iowa City, Iowa, 52242, United States

  • University Of Michigan

    Ann Arbor, Michigan, 48109, United States

  • University of Iowa_Iowa City

    Iowa City, Iowa, 52242, United States

  • University of Manitoba

    Winnipeg, Manitoba, R3T 2N2, Canada

  • Universitätsklinik für Hämatologie

    Bern, 3010, Switzerland

  • Universitätsklinik für Innere Medizin V

    Innsbruck, 6020, Austria

  • Universitätsklinikum Bonn - Institut für Experimentelle Hämatologie

    Bonn, 53127, Germany

  • Universitätsspital Zürich - Klinik für Medizinische Onkologie und Hämatologie

    Zurich, 8091, Switzerland

  • Univerzitna Nemocnica Martin

    Martin, 036 59, Slovakia

  • Uniwersytecki Szpital Dzieciecy, Dzial Krwiolecznictwa

    Lublin, 20-093, Poland

  • Uniwersytecki Szpital Kliniczny im. J.Mikulicza-Radeckiego

    Wroclaw, Lower Silesian Voivodeship, 50-556, Poland

  • Ustav Hematologie a krevni tranfuze

    Prague, 128 20, Czechia

  • Vanderbilt Hemostasis Thrombosis Clinic

    Nashville, Tennessee, 37232-9830, United States

  • Vilnius University hospital Santaros klinikos

    Vilnius, LT-08661, Lithuania

  • Vivantes Netzwerk für Gesundheit GmbH - Vivantes Klinikum im Friedrichshain

    Berlin, 10249, Germany

  • Vranovska nemocnica, a.s.

    Vranov nad Topľou, 09327, Slovakia

  • Vseobecna nemocnica Rimavska Sobota

    Rimavská Sobota, 979 12, Slovakia

  • Washington University School of Medicine_St. Louis

    St Louis, Missouri, 63110, United States

  • Wits Bara Clinical Trial Site

    Johannesburg, Gauteng, 2013, South Africa

  • Xiangya Hospital Central-South University

    Changsha, Hunan, 410008, China

  • Zentrum für Labormedizin

    Sankt Gallen, 9008, Switzerland

  • İstanbul Üniversitesi İstanbul Tıp Fakültesi Hastanesi- Onkoloji Enstitüsü

    Capa-ISTANBUL, Capa-ISTANBUL, 34093, Turkey (Türkiye)

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