AzTrials
AzTrials

Haemophilia APhase 3FRONTIER4NCT05685238

A Research Study Looking at Long-term Treatment With Mim8 in People With Haemophilia A

A Phase 3 study testing Mim8 in people with Haemophilia A and Haemophilia A With Inhibitors, run by Novo Nordisk A/S at 141 sites in 32 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This study is looking at how Mim8 works in people with haemophilia A, who either have inhibitors or do not have inhibitors. Mim8 is a new medicine that will be used to avoid bleeding episodes. Mim8 works by replacing the function of the missing clotting factor VIII (FVIII). The study will last for up to 5.5 years. Read more about this study

Who is it for?
Any age
Conditions the study is for
Haemophilia A, Haemophilia A With Inhibitors
What is being tested?
Mim8
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
451 participants
Where
141 sitesin 32 countries
Study dates
13 Feb 2023to 30 Jun 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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 with diagnosis of congenital haemophilia A based on medical records.
  • 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:
  • 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,
  • Participant has completed the end of treatment visit for study NN7769-4514, NN7769-4516 or NN7769-4728.
  • 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.
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  • 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 with diagnosis of congenital severe haemophilia A (endogenous FVIII activity less than (<) 1 percentage [%]) with or without FVIII inhibitors based on medical records.
  • Aged <1 year at the time of signing informed consent.
  • Body weight greater than or equal to (≥) 3.2 kilograms at the time of signing informed consent.
  • 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).
  • Full-term pregnancy (gestational age ≥37 weeks).
  • 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.
  • 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.
  • Receipt of vitamin K prophylaxis (as per local standard practice).
  • Availability of historical results in medical records for:
  • activated partial thromboplastin time (aPTT)
  • FVIII levels.
  • Availability of historical results in medical records or pre-dose sample taken for:
  • fibrinogen
  • haematology parameters
  • biochemistry parameters (aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT), bilirubin and creatinine).

Who cannot join

  • 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.
  • Participant who has discontinued or been withdrawn from studies NN7769-4513, NN7769-4514, NN7769-4516, or NN7769-4728.
  • Previous participation in this study. Participation is defined as signed informed consent.
  • Female who is pregnant, breast-feeding or intends to become pregnant.
  • 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).
  • 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.
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  • Any planned major surgery, during part 1 of the study.
  • Mental incapacity, unwillingness to cooperate, or a language barrier precluding adequate understanding and cooperation.
  • Arm 3:
  • Known or suspected hypersensitivity to trial product or related products.
  • Previous participation in study 4532. Participation is defined as signed informed consent.
  • 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.
  • 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.
  • Known congenital or acquired coagulation disorders other than haemophilia A.
  • 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.
  • Lack of adequate parental/legally acceptable representative (LAR) support to enter accurately and timely information regarding treatment and bleeding episodes into an (electronic) diary.
  • 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.
  • Any planned major surgery, during part 1 of Arm 3 (infant). For definition of major surgery.
  • Immune tolerance induction planned to take place after treatment initiation.
  • 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.
  • Serum creatinine above 1.5 times the ULN.

Trial locations and contacts

141 sites in 32 countries.

141 sites in 32 countries

United States15 sites

  • Children's Healthcare Atlanta

    Atlanta, Georgia, 30329

  • UC Denver Hemoph & Thrombo Ctr

    Aurora, Colorado, 80045

  • Rush University Med. Cntr

    Chicago, Illinois, 60612

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Univ Hosp Cleveland Med Ctr

    Cleveland, Ohio, 44106

  • Dayton Children Hemostati Ctr

    Dayton, Ohio, 45404

  • Central Michigan University

    Detroit, Michigan, 48201

  • Penn State MS Hershey Med Ctr

    Hershey, Pennsylvania, 17033-2360

  • Indiana Hemophilia-Thromb Ctr

    Indianapolis, Indiana, 46260

  • University of Iowa_Iowa City

    Iowa City, Iowa, 52242

  • Children's Hospital Los Angeles - Endocrinology

    Los Angeles, California, 90027

  • Univ of Miami/SCCC

    Miami, Florida, 33136

  • Vanderbilt U Med Ctr_Nashville

    Nashville, Tennessee, 37212

  • St Christopher Hosp for Child

    Philadelphia, Pennsylvania, 19134

  • St Joseph's Hospital Foundation

    Tampa, Florida, 33607

Other trials in United States

China13 sites

  • Beijing Children's Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100045

  • Beijing Children's Hospital，Capital Medical University

    Beijing, Beijing Municipality, 100045

  • Xiangya Hospital Central-South University

    Changsha, Hunan, 410008

  • Chengdu Women's and Children's Central Hospital

    Chengdu, Sichuan, 610074

  • Haemotology, Nanfang Hospital, Southern Medical University

    Guangzhou, Guangdong, 510515

  • Nanfang Hospital, Southern Medical University-Haematology

    Guangzhou, Guangdong, 510515

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

    Huzhou, Zhejiang, 313200

  • Jinan Central Hospital Affiliated to Shandong University

    Jinan, Shandong, 250062

  • Jinan Central Hospital

    Jinan, Shandong, 250062

  • Jinan Central Hospital

    Jinan, 250062

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

    Tianjin, Tianjin Municipality, 300020

  • Tongji Hospital, Tongji Medical College of HUST

    Wuhan, Hubei, 430030

  • Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology-Hematology

    Wuhan, Hubei, 430030

Other trials in China

Turkey (Türkiye)13 sites

  • Acıbadem Adana Hastanesi-Hematoloji

    Adana, 01130

  • Gazi University

    Ankara, Beşevler/Ankara, 06500

  • Gazi Üniversitesi Hastanesi- Hematoloji

    Ankara, Beşevler/Ankara, 06500

  • Hacettepe Universitesi

    Ankara, 06100

  • Hacettepe Üniversitesi Hastanesi- Hematoloji

    Ankara, 06100

  • Akdeniz Üniversitesi Hastanesi- Hematoloji

    Antalya, Konyaaltı/ Antalya, 01010

  • Akdeniz Universitesi

    Antalya, 01010

  • Ege Universitesi Tip Fakultesi

    Bornova-IZMIR, 35100

  • Ege Üniversitesi Hastanesi- Hematoloji

    Bornova-IZMIR, 35100

  • Istanbul University Oncology Institute

    Capa-ISTANBUL, Capa-ISTANBUL, 34093

  • İstanbul Üniversitesi İstanbul Tıp Fakültesi Hastanesi- Onkoloji Enstitüsü

    Capa-ISTANBUL, Capa-ISTANBUL, 34093

  • Trakya University

    Edirne, 22030

  • Trakya Üniversitesi Tıp Fakültesi Hastanesi-Hematoloji

    Edirne, 22030

Other trials in Turkey (Türkiye)

Italy9 sites

  • AOU Careggi Firenze

    Florence, 50134

  • IRCCS Humanitas Research Hospital - Centro Trombosi e Malattie Emorragiche

    Milan, 20089

  • Fondazione IRCSS Ca' Granda Ospedale Maggiore Policlinico

    Milan, 20122

  • Azienda Ospedaliera di Rilievo Nazionale Santobono Pausilipon

    Naples, 80122

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

    Naples, 80122

  • Ospedale Pediatrico Bambino Ges

    Roma, 00165

  • A.O.U. Policlinico Umberto I

    Rome, Lazio, 00161

  • A.O.U. Policlinico Umberto I

    Rome, 00161

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

    Torino, 10126

Other trials in Italy

Japan9 sites

  • Nagoya University Hospital_Blood Transfusion

    Aichi, 466-8560

  • Ota Memorial Hospital_Pediatrics

    Gunma, 373-8585

  • Nara Medical University Hospital_Pediatrics

    Nara, 634-8522

  • Saitama Children's Med Centre_Hematology-Oncology

    Saitama, 330-8777

  • Jichi Medical University Hospital_Hematology

    Tochigi, 329-0498

  • Jichi Medical University Hospital_Pediatrics

    Tochigi, 329-0498

  • National Center for Child Health and Development_Hematology

    Tokyo, 157-8535

  • Tokyo Medical Univ. Hospital_Laboratory Medicine

    Tokyo, 160-0023

  • Ogikubo Hospital_Pediatries & Blood

    Tokyo, 167-0035

Other trials in Japan

India8 sites

  • SMS Medical College & Hospital

    Jaipur, Rajasthan, 302004

  • Christian Medical College and Hospital

    Ludhiana, Punjab, 141008

  • Seth GS medical college and KEM Hospital

    Mumbai, Maharashtra, 400012

  • Seth GS medical college and KEM Hospital

    Mumbai, 400012

  • Post Graduate Institute of Child Health

    Noida, Uttar Pradesh, 201303

  • Sahyadri Clinical Research And Development Center

    Pune, Maharashtra, 411004

  • CMCV

    Ranipet, Tamil Nadu, 632517

  • Nirmal Hospital Pvt. Ltd.

    Surat, Gujarat, 395002

Other trials in India

France7 sites

  • Hospices Civils de Lyon- Hopital Louis Pradel

    Bron, 69500

  • Ap-Hp-Hopital de Bicetre-1

    Le Kremlin-Bicêtre, 94275

  • Ap-Hp-Hopital de Bicetre

    Le Kremlin-Bicêtre, 94275

  • Centre Hospitalier Universitaire de Lille-Institut Coeur Poumon

    Lille, 59037

  • INSTITUT COEUR POUMON_Service d'hémostase et transfusion

    Lille, 59037

  • Centre Hospitalier Universitaire de Nantes-Hopital Hotel-Dieu

    Nantes, 44000

  • Centre Hospitalier Universitaire de Nantes-Hopital Hotel-Dieu

    Nantes, Nantes

Other trials in France

Poland7 sites

  • Szpital Uniwersytecki, Oddzial Kliniczny Hematologii

    Krakow, 30-688

  • Uniwersytecki Szpital Dzieciecy, Dzial Krwiolecznictwa

    Lublin, 20-093

  • Uniwersytecki Szpital Kliniczny W Poznaniu

    Poznan, Greater Poland Voivodeship, 60-569

  • Instytut Hematologii i Transfuzjologii

    Warsaw, Masovian Voivodeship, 02-776

  • Intytut Hematologii i Transfuzjologii

    Warsaw, Masovian Voivodeship, 02-776

  • Uniwersytecki Szpital Kliniczny im. J.Mikulicza-Radeckiego

    Wroclaw, Lower Silesian Voivodeship, 50-556

  • Uniwersytecki Szpital Kliniczny im. J.Mikulicza-Radeckiego

    Wroclaw, 50-556

Other trials in Poland

United Kingdom7 sites

  • Belfast City Hospital

    Belfast, BT9 78B

  • University Hospital of Wales - Haemophilia

    Cardiff, CF14 4XW

  • Royal Free Haemophilia Comprehensive Care Center

    London, NW3 2QG

  • Royal Free Hospital - Haemophilia

    London, NW3 2QG

  • Evelina London Children's Hospital - Haemophilia

    London, SE1 7EH

  • St Thomas' Hospital - Haemostasis and Thrombosis Centre

    London, SE1 7EH

  • Royal Hallamshire Hospital

    Sheffield, S10 2JF

Other trials in United Kingdom

Spain5 sites

  • Hospital Vall d'Hebron

    Barcelona, 08035

  • Hospital Sant Joan de Déu

    Esplugues Llobregat, 08950

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Carlos Haya

    Málaga, 29010

  • Hospital Regional Universitario de Málaga

    Málaga, 29010

Other trials in Spain

Portugal4 sites

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

    Coimbra, 3000-459

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

    Lisbon, 1169-045

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

    Porto, 4050-342

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

    Porto, 4200-319

Other trials in Portugal

South Korea4 sites

  • Daejeon Eulji Medical Center, Eulji University

    Daejeon, 35233

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

  • Gangdong Kyung Hee University Hospital

    Seoul, 05278

  • Kyung Hee University Hospital at Gangdong

    Seoul, 05278

Other trials in South Korea

Switzerland4 sites

  • Universitätsklinik für Hämatologie

    Bern, 3010

  • Pädiatrische Onkologie-Hämatologie

    Lucerne, 6000

  • Zentrum für Labormedizin

    Sankt Gallen, 9008

  • Universitätsspital Zürich - Klinik für Medizinische Onkologie und Hämatologie

    Zurich, 8091

Other trials in Switzerland

Taiwan4 sites

  • Chung Shan Medical University Hospital

    Taichung, 402

  • Taichung Veterans General Hospital

    Taichung, 407

  • National Taiwan University Hospital_main

    Taipei, 100

  • National Taiwan University Hospital

    Taipei, 100

Other trials in Taiwan

Austria3 sites

  • Universitätsklinik für Innere Medizin V

    Innsbruck, 6020

  • Universitätsklinik für Innere Medizin V

    Innsbruck, A 6020

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

    Vienna, 1090

Other trials in Austria

Germany3 sites

  • Vivantes Netzwerk für Gesundheit GmbH - Vivantes Klinikum im Friedrichshain

    Berlin, 10249

  • Universitätsklinikum Bonn - Institut für Experimentelle Hämatologie

    Bonn, 53127

  • HZRM Haemophilie-Zentrum Rhein Main GmbH

    Frankfurt am Main, 60596

Other trials in Germany

Slovakia3 sites

  • Univerzitna Nemocnica Martin

    Martin, 036 59

  • Vseobecna nemocnica Rimavska Sobota

    Rimavská Sobota, 979 01

  • Vranovska nemocnica, a.s.

    Vranov nad Topľou, 09327

Other trials in Slovakia

Belgium2 sites

  • Cliniques universitaires Saint-Luc - Service Hématologie

    Brussels, 1200

  • UZ Leuven - Kindergeneeskunde

    Leuven, 3000

Other trials in Belgium

Canada2 sites

  • McMaster University

    Hamilton, Ontario, L8N 3Z5

  • The Hospital for Sick Children

    Toronto, Ontario, M5G 1X8

Other trials in Canada

Latvia2 sites

  • Stradini Clinic of Oncology

    Riga, 1002

  • Children University Clinical Hospital

    Riga, 1004

Other trials in Latvia

Lithuania2 sites

  • Vilnius University hospital Santaros klinikos

    Vilnius, 08661

  • Centre of Oncology and Hematology, Vilnius University

    Vilnius, LT-08406

Other trials in Lithuania

Malaysia2 sites

  • Hospital Ampang

    Ampang, Selangor, Selangor, 68000

  • Hospital Queen Elizabeth 1

    Kota Kinabalu, Sabah, 88586

Other trials in Malaysia

Netherlands2 sites

  • AmsterdamUMC AMC

    Amsterdam, 1105 AZ

  • UMC Utrecht, Van Creveldkliniek

    Utrecht, 3584 CX

Other trials in Netherlands

Serbia2 sites

  • Clinical Centre of Serbia, Institute for Haematology

    Belgrade, 11000

  • Clinical Centre of Vojvodina

    Novi Sad, 21000

Other trials in Serbia

South Africa2 sites

  • Wits Bara Clinical Trial Site

    Johannesburg, Gauteng, 2013

  • Charlotte Maxeke Johannesburg Academic Hospital

    Parktown, Johannesburg, Gauteng, 2193

Other trials in South Africa

Bulgaria1 site

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

    Sofia, 1797

Other trials in Bulgaria

Denmark1 site

  • Rigshospitalet - Department of Haematology, 2081

    København Ø, 2100

Other trials in Denmark

Ireland1 site

  • St James's CRF

    Dublin, Leinster, D08 A978

Other trials in Ireland

Israel1 site

  • Sheba MC - The Israeli National Hemophilia Center

    Tel Litwinsky, 52621

Other trials in Israel

Mexico1 site

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

    Mérida, 97130

Other trials in Mexico

Romania1 site

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

    Cluj-Napoca, 400015

Other trials in Romania

Saudi Arabia1 site

  • King Faisal Specialist Hospital & Research Centre, Riyadh

    Riyadh, 12713

Other trials in Saudi Arabia

About this study

Official title: Open-label, Long-term Safety and Efficacy Study of Mim8 in Participants With Haemophilia A With or Without Inhibitors

This study is looking at how Mim8 works in people with haemophilia A, who either have inhibitors or do not have inhibitors. Mim8 is a new medicine that will be used to avoid bleeding episodes. Mim8 works by replacing the function of the missing clotting factor VIII (FVIII). The study will last for up to 5.5 years. The duration of the study depends on when the participant enrolled in this study. The study will end if Mim8 is approved and marketed in participant's country during the study, or the study will end in June 2028, whichever comes first. Participants will get up to 262 injections; the number of injections depends on how often participants will get injections and how long time participants take part in the study. While taking part in this study, there are some restrictions about what medicine participants can use. The study doctor will tell the participants more about this. In case the participants experience bleeds, these can be treated with additional haemostatic medicine as agreed with the study doctor. Female participants cannot take part if they are pregnant, breast-feeding or plan to get pregnant during the study period.

Being tested
Mim8
Medical subject headings
Hemophilia A

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mim8Drug

    Participants in arm 1 will administer Mim8 using an enhanced cartridge and switch to the DV3407 pen-injector once it is approved. Participants in arm 2 and 3 will use the DV3407 pen injector.

Study groups in NCT05685238
Study groupRoleWhat they receive
Arm 1ExperimentalParticipants entering from the multiple ascending dose (MAD) part of study NN7769-4513. In part 1, participants will receive Mim8 prophylaxis (PPX) subcutaneous (s.c.) administration using enhanced cartridge for 26 weeks. In part 2, participants will receive Mim8 PPX s.c. administration using enhanced cartridge or DV3407 pen-injector once it is approved.
Receives: Drug: Mim8
Arm 2ExperimentalParticipants entering from study NN7769-4514, NN7769-4728 and NN7769-4516. In part 1, participants will receive Mim8 PPX s.c. administration using DV3407 pen-injector for 26 weeks. In part 2, participants will receive Mim8 PPX s.c. administration using DV3407 pen-injector.
Receives: Drug: Mim8
Arm 3ExperimentalIn part 1 and 2, participants will receive Mim8 PPX s.c. administration using DV3407 pen-injector.
Receives: Drug: Mim8

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Arm 1 and 2: Number of treatment emergent adverse events

    Measured as count of events.

    Measured: From week 0 until end of study (up to 283 weeks)

  2. Arm 3: Number of treatment emergent adverse events

    Measured as count of events.

    Measured: From treatment initiation (week 0) until end of study (up to 124 weeks)

Secondary outcomes (16)

  1. Arm 1 and 2: Number of injection site reactions

    Measured as count of reactions.

    Measured: From week 0 until end of treatment (up to 262 weeks)

  2. Arm 1 and 2: Occurrence of anti Mim8 antibodies

    Measured as count of participants.

    Measured: From week 0 until end of treatment (up to 262 weeks)

  3. Arm 1 and 2: Number of treated bleeding episodes

    Measured as count of bleeds.

    Measured: From week 0 until end of treatment (up to 262 weeks)

  4. Arm 1 and 2: Number of treated spontaneous bleeding episodes

    Measured as count of bleeds.

    Measured: From week 0 until end of treatment (up to 262 weeks)

  5. Arm 1 and 2: Number of treated traumatic bleeding episodes

    Measured as count of bleeds.

    Measured: From week 0 until end of treatment (up to 262 weeks)

  6. Arm 1 and 2: Number of treated joint bleeding episodes

    Measured as count of bleeds.

    Measured: From week 0 until end of treatment (up to 262 weeks)

  7. Arm 2: Number of treated target joint bleeding episodes

    Measured as count of bleeds.

    Measured: From week 0 until end of treatment (up to 262 weeks)

  8. Arm 1 and 2: Mim8 plasma concentration

    Measured as micrograms per milliliter (µg/mL).

    Measured: From week 0 until end of treatment (up to 262 weeks)

  9. Arm 2: Device handling using haemophilia device assessment tool (HDAT) (applicable for participants in arm 2 only)

    Measured as percentage of participants.

    Measured: From week 26 until end of treatment (up to 262 weeks)

  10. Arm 3: Number of injection site reactions

    Measured as count of reactions.

    Measured: From treatment initiation (week 0) until end of treatment (up to 103 weeks)

  11. Arm 3: Occurrence of anti Mim8 antibodies

    Measured as count of participants.

    Measured: From treatment initiation (week 0) until end of treatment (up to 103 weeks)

  12. Arm 3: Number of treated bleeding episodes

    Measured as count of bleeds.

    Measured: From treatment initiation (week 0) until end of treatment (up to 103 weeks)

  13. Arm 3: Number of treated spontaneous bleeding episodes

    Measured as count of bleeds.

    Measured: From treatment initiation (week 0) until end of treatment (up to 103 weeks)

  14. Arm 3: Number of treated traumatic bleeding episodes

    Measured as count of bleeds.

    Measured: From treatment initiation (week 0) until end of treatment (up to 103 weeks)

  15. Arm 3: Mim8 plasma concentration

    Measured as µg/mL.

    Measured: From treatment initiation (week 0) until end of treatment (up to 103 weeks)

  16. Arm 3: Device handling using haemophilia device assessment tool (HDAT)

    Measured as percentage of participants.

    Measured: At week 26 and week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jan 2023
  2. Study start13 Feb 2023
  3. Primary completion30 Jun 2028 (estimated)
  4. Study completion30 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
451 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05685238
Sponsor's protocol ID
NN7769-4532
Other IDs
U1111-1274-4426, 2022-502215-10
Acronym
FRONTIER4
Status last verified
Sep 2026
First submitted
4 Jan 2023
Last updated
9 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.

Publications

  • Matsushita T, Banchev A, Bovet J, Chowdary P, Garcia Fernandez LM, Jimenez-Yuste V, Kavakli K, Kremer Hovinga JA, Windyga J, Young G. Denecimig (Mim8) prophylaxis once-every-2-weeks for hemophilia A with or without inhibitors - 26-week results from FRONTIER. Blood Adv. 2026 Jul 17:bloodadvances.2025019095. doi: 10.1182/bloodadvances.2025019095. Online ahead of print.

    PubMed 42469164

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Mim8 in people with Haemophilia A and Haemophilia A With Inhibitors, run by Novo Nordisk A/S at 141 sites in 32 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 141 sites in United States, China, Turkey (Türkiye), Italy, Japan and 27 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Arm 1 and 2: Number of treatment emergent adverse events (time frame: From week 0 until end of study (up to 283 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05685238, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.

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