A Research Study Looking at Long-term Treatment With Mim8 in People With Haemophilia A (FRONTIER 4)

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

451

Participants

Timeline

Start Date

February 13, 2023

Primary Completion Date

June 30, 2028

Study Completion Date

June 30, 2028

Conditions
Haemophilia AHaemophilia A With Inhibitors
Interventions
DRUG

Mim8

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.

Trial Locations (128)

100

National Taiwan University Hospital_main, Taipei

National Taiwan University Hospital, Taipei

402

Chung Shan Medical University Hospital, Taichung

407

Taichung Veterans General Hospital, Taichung

1002

Stradini Clinic of Oncology, Riga

1004

Children University Clinical Hospital, Riga

1090

AKH - Klin. Abt. f. Haematologie u. Haemostaseologie, Vienna

1200

Cliniques universitaires Saint-Luc - Service Hématologie, Brussels

1527

UMHAT Tsaritsa Yoanna-ISUL EAD, Sofia

2013

Wits Bara Clinical Trial Site, Johannesburg

2100

Department of Haematology, 2081, København Ø

2193

Charlotte Maxeke Johannesburg Academic Hospital, Parktown, Johannesburg

3000

UZ Leuven - Kindergeneeskunde, Leuven

3010

Universitätsklinik für Hämatologie, Bern

6000

Pädiatrische Onkologie-Hämatologie, Lucerne

6020

Universitätsklinik für Innere Medizin V, Innsbruck

8091

Universitätsspital Zürich - Klinik für Medizinische Onkologie und Hämatologie, Zurich

9008

Zentrum für Labormedizin, Sankt Gallen

10249

Vivantes Netzwerk für Gesundheit GmbH - Vivantes Klinikum im Friedrichshain, Berlin

11000

Clinical Centre of Serbia, Institute for Haematology, Belgrade

12713

King Faisal Specialist Hospital & Research Centre, Riyadh, Riyadh

19134

St Christopher Hosp for Child, Philadelphia

20089

Ist Clinico Humanitas Centro Trombosi e Malattie Emorragiche, Milan

20122

Fondazione IRCSS Ca' Granda Ospedale Maggiore Policlinico, Milan

21000

Clinical Centre of Vojvodina, Novi Sad

22030

Trakya University, Edirne

28046

Hospital Universitario La Paz, Madrid

29010

Hospital Carlos Haya, Málaga

Hospital Regional Universitario de Málaga, Málaga

30329

Children's Healthcare Atlanta, Atlanta

33136

Univ of Miami/SCCC, Miami

33607

St Joseph's Children's Hospita, Tampa

34093

Istanbul University Oncology Institute, Capa-ISTANBUL

35100

Ege Universitesi Tip Fakultesi, Bornova-IZMIR

35233

Daejeon Eulji Medical Center, Eulji University, Daejeon

37212

Vanderbilt U Med Ctr_Nashville, Nashville

44106

Univ Hosp Cleveland Med Ctr, Cleveland

45404

Dayton Children Hemostati Ctr, Dayton

48201

Central Michigan University, Detroit

50134

AOU Careggi Firenze, Florence

52242

University of Iowa_Iowa City, Iowa City

52621

Sheba MC - The Israeli National Hemophilia Center, Tel Litwinsky

53127

Universitätsklinikum Bonn - Institut für Experimentelle Hämatologie, Bonn

59037

Centre Hospitalier Universitaire de Lille-Institut Coeur Poumon, Lille

60596

HZRM Haemophilie-Zentrum Rhein Main GmbH, Frankfurt am Main

60612

Rush University Medical Center, Chicago

68000

Hospital Ampang, Ampang, Selangor

69500

Hospices Civils de Lyon-Hopital Cardiologique Louis Pradel-1, Bron

80045

UC Denver Hemoph & Thrombo Ctr, Aurora

80122

Azienda Ospedaliera di Rilievo Nazionale Santobono Pausilipon, Napoli

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

88586

Hospital Queen Elizabeth 1, Kota Kinabalu

90027

Children's Hospital Los Angeles - Endocrinology, Los Angeles

94275

Ap-Hp-Hopital de Bicetre-1, Le Kremlin-Bicêtre

97130

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

100045

Beijing Children's Hospital, Capital Medical University, Beijing

Beijing Children's Hospital,Capital Medical University, Beijing

141008

Christian Medical College and Hospital, Ludhiana

201303

Post Graduate Institute of Child Health, Noida

250062

Jinan Central Hospital Affiliated to Shandong University, Jinan

Jinan Central Hospital, Jinan

300020

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

302004

SMS Medical College & Hospital, Jaipur

310052

Children's Hospital, Zhejiang University School of Medicine, Hangzhou

395002

Nirmal Hospital Pvt. Ltd., Surat

400012

Seth GS medical college and KEM Hospital, Mumbai

Seth GS medical college and KEM Hospital, Mumbai

400015

"Institut Oncologic Prof. Dr. Ion Chiricuta Cluj Napoca", Cluj-Napoca

410008

Xiangya Hospital Central-South University, Changsha

411004

Sahyadri Clinical Research And Development Center, Pune

430030

Tongji Hospital, Tongji Medical College of HUST-Hematology, Wuhan

Tongji Hospital, Tongji Medical College of HUST, Wuhan

510515

Haemotology, Nanfang Hospital, Southern Medical University, Guangzhou

Nanfang Hospital, Southern Medical University-Haematology, Guangzhou

610074

Chengdu Women's and Children's Central Hospital, Chengdu

632517

CMCV, Ranipet

17033-2360

Penn State MS Hershey Med Ctr, Hershey

A 6020

Universitätsklinik für Innere Medizin V, Innsbruck

L8N 3Z5

McMaster University, Hamilton

M5G 1X8

The Hospital for Sick Children, Toronto

Nantes

Centre Hospitalier Universitaire de Nantes-Hopital Hotel-Dieu, Nantes

D08 A978

St James's CRF, Dublin

00161

A.O.U. Policlinico Umberto I, Rome

A.O.U. Policlinico Umberto I, Rome

00165

Ospedale Pediatrico Bambino Ges, Roma

466-8560

Nagoya University Hospital_Blood Transfusion, Aichi

373-8585

Ota Memorial Hospital_Pediatrics, Gunma

634-8522

Nara Medical University Hospital_Pediatrics, Nara

330-8777

Saitama Children's Med Centre_Hematology-Oncology, Saitama

329-0498

Jichi Medical University Hospital_Hematology, Tochigi

Jichi Medical University Hospital_Pediatrics, Tochigi

157-8535

National Center for Child Health and Development_Hematology, Tokyo

160-0023

Tokyo Medical Univ. Hospital_Laboratory Medicine, Tokyo

167-0035

Ogikubo Hospital_Pediatries & Blood, Tokyo

08661

Vilnius University hospital Santaros klinikos, Vilnius

LT-08406

Centre of Oncology and Hematology, Vilnius University, Vilnius

1105 AZ

Academisch Medisch Centrum, Amsterdam

3584 CX

UMC Utrecht, Van Creveldkliniek, Utrecht

60-569

Uniwersytecki Szpital Kliniczny W Poznaniu, Poznan

50-556

Uniwersytecki Szpital Kliniczny im. J.Mikulicza-Radeckiego, Wroclaw

Uniwersytecki Szpital Kliniczny im. J.Mikulicza-Radeckiego, Wroclaw

02-776

Instytut Hematologii i Transfuzjologii, Warsaw

Intytut Hematologii i Transfuzjologii, Warsaw

30-688

Szpital Uniwersytecki, Oddzial Kliniczny Hematologii, Krakow

20-093

Uniwersytecki Szpital Dzieciecy, Dzial Krwiolecznictwa, Lublin

3000-459

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

1169-045

Unidade Local de Saúde São José EPE- Hospital D. Estefânia, Lisbon

4050-342

Centro Hospitalar Universitario De Santo Antonio E.P.E, Porto

4200-319

Unidade Local de Saude de Sao Joao E.P.E, Porto

036 59

Univerzitna Nemocnica Martin, Martin

979 01

Vseobecna nemocnica Rimavska Sobota, Rimavská Sobota

09327

Vranovska nemocnica, a.s., Vranov nad Topľou

03722

Severance Hospital, Yonsei University Health System, Seoul

05278

Gangdong Kyung Hee University Hospital, Seoul

08035

Hospital Vall d'Hebron, Barcelona

08950

Hospital Sant Joan de Déu, Esplugues Llobregat

06500

Gazi University, Ankara

01010

Akdeniz Universitesi, Antalya

Akdeniz Universitesi, Antalya

01130

Acibadem Adana Hastanesi, Adana

06100

Hacettepe Universitesi, Ankara

BT9 78B

Belfast City Hospital, Belfast

CF14 4XW

Arthur Bloom Haemophilia Centre, Cardiff

NW3 2QG

Royal Free Haemophilia Comprehensive Care Center, London

Royal Free Haemophilia Comprehensive Care Centre, London

SE1 7EH

Evelina London Children's Hospital, London

St Thomas' Hospital - Haemostasis and Thrombosis Centre, London

S10 2JF

Royal Hallamshire Hospital, Sheffield

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novo Nordisk A/S

INDUSTRY