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New drug Mim8 shows promise for Long-Term bleeding prevention in hemophilia a

NCT ID NCT05685238

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Sep 10, 2026 · Updated 5 times

Summary

This study tests Mim8, a drug that helps blood clot by mimicking a missing protein, in people with hemophilia A (with or without inhibitors). Over 450 participants will receive injections for up to 5.5 years to see if it safely prevents bleeding episodes. The goal is to provide a long-term treatment option that reduces the need for other medications.

What this could mean

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

Active substance
Mim8
What this could lead to
If successful, Mim8 could offer a long-term, convenient option to prevent bleeding episodes in people with hemophilia A, reducing the need for frequent infusions.
What could go wrong
This is an extension study, so early results are already promising, but long-term safety and effectiveness are still being confirmed. Some participants may experience side effects or develop antibodies against the drug.

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 451 people

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

Started

Feb 2023

Expected to finish

Jun 2028

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

Children (under 18), adults (18 to 64) and older adults (65 and over)

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.

Arm 1 \& 2: 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 with diagnosis of congenital haemophilia A based on medical records. 3. Ongoing participation in study NN7769-4513, NN7769-4514, NN7769-4516, or NN7769-4728 at the time of transfer. Participant should qualify either of the following criteria: 1. Participant from study NN7769-4513, who has participated in the extension part of the study for at least 12 weeks prior to enrolment in study NN7769-4532, or, 2. Participant has completed the end of treatment visit for study NN7769-4514, NN7769-4516 or NN7769-4728. 4. Participant and/or participant's parent(s)/participant's Legally acceptable representative (LAR) willingness and ability to comply with scheduled visits and study procedures, including the completion of diary. Exclusion Criteria: 1. 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. 2. Participant who has discontinued or been withdrawn from studies NN7769-4513, NN7769-4514, NN7769-4516, or NN7769-4728. 3. Previous participation in this study. Participation is defined as signed informed consent. 4. Female who is pregnant, breast-feeding or intends to become pregnant. 5. Female of child-bearing potential and not using a highly effective contraceptive method (highly effective contraceptive measures or as required by local regulation or practice). 6. Participation (i.e., signed informed consent) in any interventional, clinical study (except from study NN7769-4513, NN7769-4514, NN7769-4516, or NN7769-4728) of an approved or non-approved investigational medicinal product. 7. Any planned major surgery, during part 1 of the study. 8. Mental incapacity, unwillingness to cooperate, or a language barrier precluding adequate understanding and cooperation. Arm 3: 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 with diagnosis of congenital severe haemophilia A (endogenous FVIII activity less than (\<) 1 percentage \[%\]) with or without FVIII inhibitors based on medical records. 3. Aged \<1 year at the time of signing informed consent. 4. Body weight greater than or equal to (≥) 3.2 kilograms at the time of signing informed consent. 5. previously untreated patients (PUPs) or minimally treated patients (MTPs) (i.e., up to 5 days of exposure to haemophilia-related treatment such as plasma-derived FVIII, recombinant FVIII, fresh frozen plasma, cryoprecipitate, or whole blood products). 6. Full-term pregnancy (gestational age ≥37 weeks). 7. Participant's parent(s)/LAR(s) willingness and ability to comply with scheduled visits and Arm 3 (infant) procedures, including the completion of diary and patient reported outcome (PRO) questionnaire. 8. Participants \<3 months of age must show no signs of active intracranial haemorrhage at screening. This is confirmed by cranial ultrasound performed according to local practice and regardless of delivery method. 9. Receipt of vitamin K prophylaxis (as per local standard practice). 10. Availability of historical results in medical records for: 1. activated partial thromboplastin time (aPTT) 2. FVIII levels. 11. Availability of historical results in medical records or pre-dose sample taken for: 1. fibrinogen 2. haematology parameters 3. biochemistry parameters (aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT), bilirubin and creatinine). Exclusion criteria 1. Known or suspected hypersensitivity to trial product or related products. 2. Previous participation in study 4532. Participation is defined as signed informed consent. 3. 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 enrolment. 4. 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 enrolment. 5. Known congenital or acquired coagulation disorders other than haemophilia A. 6. Other conditions (e.g., autoimmune disease) or laboratory abnormality that may increase the risk of bleeding or thrombosis, as evaluated by the investigator. Any disorder, except for conditions associated with haemophilia A, that in the investigator's opinion might jeopardise the participant's safety or compliance with the protocol. 7. Lack of adequate parental/legally acceptable representative (LAR) support to enter accurately and timely information regarding treatment and bleeding episodes into an (electronic) diary. 8. Previous or current treatment for thromboembolic disease (with the exception of previous catheter-associated thrombosis for which anti-thrombotic treatment is not currently ongoing) or signs of thromboembolic disease. 9. Any planned major surgery, during part 1 of Arm 3 (infant). For definition of major surgery. 10. Immune tolerance induction planned to take place after treatment initiation. 11. Hepatic dysfunction defined as AST and/or ALT greater than (\>) 3 times the upper limit of normal (ULN) combined with total bilirubin \>1.5 times the ULN. 12. Serum creatinine above 1.5 times the ULN.

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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

  • A.O.U. Policlinico Umberto I

    Rome, Lazio, 00161, Italy

  • A.O.U. Policlinico Umberto I

    Rome, 00161, Italy

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

    Vienna, 1090, Austria

  • AOU Careggi Firenze

    Florence, 50134, Italy

  • AOU Città della Salute e della Scienza di Torino - Ospedale Regina Margherita

    Torino, 10126, Italy

  • Acıbadem Adana Hastanesi-Hematoloji

    Adana, 01130, Turkey (Türkiye)

  • Akdeniz Universitesi

    Antalya, 01010, Turkey (Türkiye)

  • Akdeniz Üniversitesi Hastanesi- Hematoloji

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

  • AmsterdamUMC AMC

    Amsterdam, 1105 AZ, Netherlands

  • Ap-Hp-Hopital de Bicetre

    Le Kremlin-Bicêtre, 94275, France

  • Ap-Hp-Hopital de Bicetre-1

    Le Kremlin-Bicêtre, 94275, France

  • Azienda Ospedaliera Santobono Pausilipon - U.S.D. Centro Regionale Pediatrico Malattie della Coagulazione

    Naples, 80122, Italy

  • Azienda Ospedaliera di Rilievo Nazionale Santobono Pausilipon

    Naples, 80122, Italy

  • Beijing Children's Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100045, China

  • Beijing Children's Hospital，Capital Medical University

    Beijing, Beijing Municipality, 100045, China

  • Belfast City Hospital

    Belfast, BT9 78B, United Kingdom

  • CMCV

    Ranipet, Tamil Nadu, 632517, India

  • Central Michigan University

    Detroit, Michigan, 48201, United States

  • Centre Hospitalier Universitaire de Lille-Institut Coeur Poumon

    Lille, 59037, France

  • Centre Hospitalier Universitaire de Nantes-Hopital Hotel-Dieu

    Nantes, 44000, France

  • Centre Hospitalier Universitaire de Nantes-Hopital Hotel-Dieu

    Nantes, Nantes, France

  • Centre of Oncology and Hematology, Vilnius University

    Vilnius, LT-08406, Lithuania

  • 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 University Clinical Hospital

    Riga, 1004, Latvia

  • Children's Healthcare Atlanta

    Atlanta, Georgia, 30329, United States

  • Children's Hospital Los Angeles - Endocrinology

    Los Angeles, California, 90027, United States

  • Children's Hospital, Zhejiang University School of Medicine-Hematology

    Huzhou, Zhejiang, 313200, China

  • Christian Medical College and Hospital

    Ludhiana, Punjab, 141008, India

  • Chung Shan Medical University Hospital

    Taichung, 402, Taiwan

  • 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

  • Daejeon Eulji Medical Center, Eulji University

    Daejeon, 35233, South Korea

  • Dayton Children Hemostati Ctr

    Dayton, Ohio, 45404, United States

  • Ege Universitesi Tip Fakultesi

    Bornova-IZMIR, 35100, Turkey (Türkiye)

  • Ege Üniversitesi Hastanesi- Hematoloji

    Bornova-IZMIR, 35100, Turkey (Türkiye)

  • Evelina London Children's Hospital - Haemophilia

    London, SE1 7EH, United Kingdom

  • Fondazione IRCSS Ca' Granda Ospedale Maggiore Policlinico

    Milan, 20122, Italy

  • Gangdong Kyung Hee University Hospital

    Seoul, 05278, South Korea

  • 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

  • Hacettepe Universitesi

    Ankara, 06100, Turkey (Türkiye)

  • Hacettepe Üniversitesi Hastanesi- Hematoloji

    Ankara, 06100, Turkey (Türkiye)

  • Haemotology, Nanfang Hospital, Southern Medical University

    Guangzhou, Guangdong, 510515, China

  • Hospices Civils de Lyon- Hopital Louis Pradel

    Bron, 69500, France

  • Hospital Ampang

    Ampang, Selangor, Selangor, 68000, Malaysia

  • Hospital Carlos Haya

    Málaga, 29010, Spain

  • Hospital Queen Elizabeth 1

    Kota Kinabalu, Sabah, 88586, Malaysia

  • Hospital Regional Universitario de Málaga

    Málaga, 29010, Spain

  • Hospital Sant Joan de Déu

    Esplugues Llobregat, 08950, Spain

  • Hospital Universitario La Paz

    Madrid, 28046, Spain

  • Hospital Vall d'Hebron

    Barcelona, 08035, Spain

  • INSTITUT COEUR POUMON_Service d'hémostase et transfusion

    Lille, 59037, 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

  • Instytut Hematologii i Transfuzjologii

    Warsaw, Masovian Voivodeship, 02-776, Poland

  • Intytut Hematologii i Transfuzjologii

    Warsaw, Masovian Voivodeship, 02-776, Poland

  • 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

    Jinan, Shandong, 250062, China

  • Jinan Central Hospital

    Jinan, 250062, China

  • Jinan Central Hospital Affiliated to Shandong University

    Jinan, Shandong, 250062, China

  • King Faisal Specialist Hospital & Research Centre, Riyadh

    Riyadh, 12713, Saudi Arabia

  • Kyung Hee University Hospital at Gangdong

    Seoul, 05278, South Korea

  • McMaster University

    Hamilton, Ontario, L8N 3Z5, Canada

  • Nagoya University Hospital_Blood Transfusion

    Aichi, 466-8560, Japan

  • Nanfang Hospital, Southern Medical University-Haematology

    Guangzhou, Guangdong, 510515, China

  • Nara Medical University Hospital_Pediatrics

    Nara, 634-8522, Japan

  • National Center for Child Health and Development_Hematology

    Tokyo, 157-8535, Japan

  • National Taiwan University Hospital

    Taipei, 100, Taiwan

  • National Taiwan University Hospital_main

    Taipei, 100, Taiwan

  • Nirmal Hospital Pvt. Ltd.

    Surat, Gujarat, 395002, India

  • Ogikubo Hospital_Pediatries & Blood

    Tokyo, 167-0035, Japan

  • Ospedale Pediatrico Bambino Ges

    Roma, 00165, Italy

  • Ota Memorial Hospital_Pediatrics

    Gunma, 373-8585, Japan

  • Penn State MS Hershey Med Ctr

    Hershey, Pennsylvania, 17033-2360, United States

  • Post Graduate Institute of Child Health

    Noida, Uttar Pradesh, 201303, India

  • Pädiatrische Onkologie-Hämatologie

    Lucerne, 6000, Switzerland

  • Rigshospitalet - Department of Haematology, 2081

    København Ø, 2100, Denmark

  • Royal Free Haemophilia Comprehensive Care Center

    London, NW3 2QG, United Kingdom

  • Royal Free Hospital - Haemophilia

    London, NW3 2QG, United Kingdom

  • Royal Hallamshire Hospital

    Sheffield, S10 2JF, United Kingdom

  • Rush University Med. Cntr

    Chicago, Illinois, 60612, United States

  • Rush University Medical Center

    Chicago, Illinois, 60612, United States

  • SHAT of Haematological Diseases EAD, Clinic of Paediatric Clinical Haematology

    Sofia, 1797, Bulgaria

  • SMS Medical College & Hospital

    Jaipur, Rajasthan, 302004, India

  • Sahyadri Clinical Research And Development Center

    Pune, Maharashtra, 411004, India

  • Saitama Children's Med Centre_Hematology-Oncology

    Saitama, 330-8777, Japan

  • Seth GS medical college and KEM Hospital

    Mumbai, Maharashtra, 400012, India

  • Seth GS medical college and KEM Hospital

    Mumbai, 400012, India

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722, South Korea

  • Sheba MC - The Israeli National Hemophilia Center

    Tel Litwinsky, 52621, Israel

  • 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

  • Stradini Clinic of Oncology

    Riga, 1002, Latvia

  • Szpital Uniwersytecki, Oddzial Kliniczny Hematologii

    Krakow, 30-688, Poland

  • Taichung Veterans General Hospital

    Taichung, 407, Taiwan

  • The Hospital for Sick Children

    Toronto, Ontario, M5G 1X8, Canada

  • 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, Huazhong University of Science & Technology-Hematology

    Wuhan, Hubei, 430030, China

  • Trakya University

    Edirne, 22030, Turkey (Türkiye)

  • Trakya Üniversitesi Tıp Fakültesi Hastanesi-Hematoloji

    Edirne, 22030, Turkey (Türkiye)

  • UC Denver Hemoph & Thrombo Ctr

    Aurora, Colorado, 80045, United States

  • ULS De Santo António, E.P.E. _H.Santo António_ Imunohemoterapia

    Porto, 4050-342, Portugal

  • ULS De São José, E.P.E.- Hospital D. Estefânia

    Lisbon, 1169-045, Portugal

  • ULS São João, E.P.E._H.São João_Imunohemoterapia

    Porto, 4200-319, Portugal

  • UMC Utrecht, Van Creveldkliniek

    Utrecht, 3584 CX, Netherlands

  • UZ Leuven - Kindergeneeskunde

    Leuven, 3000, Belgium

  • Unidade De Coimbra, E.P.E. - Hospital da Universidade de Coimbra

    Coimbra, 3000-459, Portugal

  • Univ Hosp Cleveland Med Ctr

    Cleveland, Ohio, 44106, United States

  • Univ of Miami/SCCC

    Miami, Florida, 33136, United States

  • University Hospital of Wales - Haemophilia

    Cardiff, CF14 4XW, United Kingdom

  • University of Iowa_Iowa City

    Iowa City, Iowa, 52242, United States

  • Universitätsklinik für Hämatologie

    Bern, 3010, Switzerland

  • Universitätsklinik für Innere Medizin V

    Innsbruck, 6020, Austria

  • Universitätsklinik für Innere Medizin V

    Innsbruck, A 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 W Poznaniu

    Poznan, Greater Poland Voivodeship, 60-569, Poland

  • Uniwersytecki Szpital Kliniczny im. J.Mikulicza-Radeckiego

    Wroclaw, Lower Silesian Voivodeship, 50-556, Poland

  • Uniwersytecki Szpital Kliniczny im. J.Mikulicza-Radeckiego

    Wroclaw, 50-556, Poland

  • Vanderbilt U Med Ctr_Nashville

    Nashville, Tennessee, 37212, United States

  • Vilnius University hospital Santaros klinikos

    Vilnius, 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 01, Slovakia

  • 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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