A Research Study Looking at Long-term Treatment With Mim8 in People With Haemophilia A
Start Date
2/13/2023
Completion Date
6/30/2028
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. 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.
Eligibility Criteria
Age Range: No minimum to No maximum
Interventions
Mim8
Conditions
Locations
Children's Hospital Los Angeles - Endocrinology
Los Angeles, California 90027
United States
UC Denver Hemoph & Thrombo Ctr
Aurora, Colorado 80045
United States
Univ of Miami/SCCC
Miami, Florida 33136
United States
St Joseph's Hospital Foundation
Tampa, Florida 33607
United States
Children's Healthcare Atlanta
Atlanta, Georgia 30329
United States
Rush University Med. Cntr
Chicago, Illinois 60612
United States
Rush University Medical Center
Chicago, Illinois 60612
United States
Indiana Hemophilia-Thromb Ctr
Indianapolis, Indiana 46260
United States
University of Iowa_Iowa City
Iowa City, Iowa 52242
United States
Central Michigan University
Detroit, Michigan 48201
United States
Univ Hosp Cleveland Med Ctr
Cleveland, Ohio 44106
United States
Dayton Children Hemostati Ctr
Dayton, Ohio 45404
United States
Penn State MS Hershey Med Ctr
Hershey, Pennsylvania 17033-2360
United States
St Christopher Hosp for Child
Philadelphia, Pennsylvania 19134
United States
Vanderbilt U Med Ctr_Nashville
Nashville, Tennessee 37212
United States
Universitätsklinik für Innere Medizin V
Innsbruck, 6020
Austria
Universitätsklinik für Innere Medizin V
Innsbruck, A 6020
Austria
AKH - Klin. Abt. f. Haematologie u. Haemostaseologie
Vienna, 1090
Austria
AKH - Klin. Abt. f. Haematologie u. Haemostaseologie
Vienna, 1090
Austria
Cliniques universitaires Saint-Luc - Service Hématologie
Brussels, 1200
Belgium
UZ Leuven - Kindergeneeskunde
Leuven, 3000
Belgium
SHAT of Haematological Diseases EAD, Clinic of Paediatric Clinical Haematology
Sofia, 1797
Bulgaria
McMaster University
Hamilton, Ontario L8N 3Z5
Canada
The Hospital for Sick Children
Toronto, Ontario M5G 1X8
Canada
Beijing Children's Hospital, Capital Medical University
Beijing, Beijing Municipality 100045
China
Beijing Children's Hospital,Capital Medical University
Beijing, Beijing Municipality 100045
China
Haemotology, Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong 510515
China
Nanfang Hospital, Southern Medical University-Haematology
Guangzhou, Guangdong 510515
China
Tongji Hospital, Tongji Medical College of HUST-Hematology
Wuhan, Hubei 430030
China
Tongji Hospital, Tongji Medical College of HUST
Wuhan, Hubei 430030
China
Xiangya Hospital Central-South University
Changsha, Hunan 410008
China
Jinan Central Hospital Affiliated to Shandong University
Jinan, Shandong 250062
China
Jinan Central Hospital
Jinan, Shandong 250062
China
Chengdu Women's and Children's Central Hospital
Chengdu, Sichuan 610074
China
Institute of Hematology and Blood Diseases Hospital, Tianjin-Hematology
Tianjin, Tianjin Municipality 300020
China
Institute of hematology and Blood Diseases Hospital, Tianjin-Hematology
Tianjin, Tianjin Municipality 300020
China
Children's Hospital, Zhejiang University School of Medicine-Hematology
Huzhou, Zhejiang 313200
China
Jinan Central Hospital
Jinan, 250062
China
Rigshospitalet - Department of Haematology, 2081
København Ø, 2100
Denmark
Hospices Civils de Lyon- Hopital Louis Pradel
Bron, 69500
France
Ap-Hp-Hopital de Bicetre-1
Le Kremlin-Bicêtre, 94275
France
Ap-Hp-Hopital de Bicetre
Le Kremlin-Bicêtre, 94275
France
Centre Hospitalier Universitaire de Lille-Institut Coeur Poumon
Lille, 59037
France
INSTITUT COEUR POUMON_Service d'hémostase et transfusion
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
Vivantes Netzwerk für Gesundheit GmbH - Vivantes Klinikum im Friedrichshain
Berlin, 10249
Germany
Universitätsklinikum Bonn - Institut für Experimentelle Hämatologie
Bonn, 53127
Germany
HZRM Haemophilie-Zentrum Rhein Main GmbH
Frankfurt am Main, 60596
Germany
Nirmal Hospital Pvt. Ltd.
Surat, Gujarat 395002
India
Nirmal Hospital Pvt. Ltd.
Surat, Gujarat 395002
India
Seth GS medical college and KEM Hospital
Mumbai, Maharashtra 400012
India
Sahyadri Clinical Research And Development Center
Pune, Maharashtra 411004
India
Sahyadri Clinical Research And Development Center
Pune, Maharashtra 411004
India
Christian Medical College and Hospital
Ludhiana, Punjab 141008
India
Christian Medical College and Hospital
Ludhiana, Punjab 141008
India
SMS Medical College & Hospital
Jaipur, Rajasthan 302004
India
CMCV
Ranipet, Tamil Nadu 632517
India
Post Graduate Institute of Child Health
Noida, Uttar Pradesh 201303
India
Seth GS medical college and KEM Hospital
Mumbai, 400012
India
St James's CRF
Dublin, Leinster D08 A978
Ireland
St James's CRF
Dublin, Leinster D08 A978
Ireland
Sheba MC - The Israeli National Hemophilia Center
Tel Litwinsky, 52621
Israel
A.O.U. Policlinico Umberto I
Rome, Lazio 00161
Italy
AOU Careggi Firenze
Florence, 50134
Italy
IRCCS Humanitas Research Hospital - Centro Trombosi e Malattie Emorragiche
Milan, 20089
Italy
Fondazione IRCSS Ca' Granda Ospedale Maggiore Policlinico
Milan, 20122
Italy
Azienda Ospedaliera di Rilievo Nazionale Santobono Pausilipon
Naples, 80122
Italy
Azienda Ospedaliera Santobono Pausilipon - U.S.D. Centro Regionale Pediatrico Malattie della Coagulazione
Naples, 80122
Italy
Ospedale Pediatrico Bambino Ges
Roma, 00165
Italy
Ospedale Pediatrico Bambino Ges
Roma, 00165
Italy
A.O.U. Policlinico Umberto I
Rome, 00161
Italy
AOU Città della Salute e della Scienza di Torino - Ospedale Regina Margherita
Torino, 10126
Italy
Nagoya University Hospital_Blood Transfusion
Aichi, 466-8560
Japan
Ota Memorial Hospital_Pediatrics
Gunma, 373-8585
Japan
Nara Medical University Hospital_Pediatrics
Nara, 634-8522
Japan
Saitama Children's Med Centre_Hematology-Oncology
Saitama, 330-8777
Japan
Jichi Medical University Hospital_Hematology
Tochigi, 329-0498
Japan
Jichi Medical University Hospital_Pediatrics
Tochigi, 329-0498
Japan
National Center for Child Health and Development_Hematology
Tokyo, 157-8535
Japan
Tokyo Medical Univ. Hospital_Laboratory Medicine
Tokyo, 160-0023
Japan
Ogikubo Hospital_Pediatries & Blood
Tokyo, 167-0035
Japan
Stradini Clinic of Oncology
Riga, 1002
Latvia
Children University Clinical Hospital
Riga, 1004
Latvia
Vilnius University hospital Santaros klinikos
Vilnius, 08661
Lithuania
Centre of Oncology and Hematology, Vilnius University
Vilnius, LT-08406
Lithuania
Hospital Queen Elizabeth 1
Kota Kinabalu, Sabah 88586
Malaysia
Hospital Ampang
Ampang, Selangor, Selangor 68000
Malaysia
Hospital Ampang
Ampang, Selangor, Selangor 68000
Malaysia
Centro Multidisciplinario Para El Desarrollo Especializado De La Investigación Clínica En Yucatán S.C.P. (CEMDEICY S.C.P.)
Mérida, 97130
Mexico
AmsterdamUMC AMC
Amsterdam, 1105 AZ
Netherlands
UMC Utrecht, Van Creveldkliniek
Utrecht, 3584 CX
Netherlands
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
Instytut Hematologii i Transfuzjologii
Warsaw, Masovian Voivodeship 02-776
Poland
Intytut Hematologii i Transfuzjologii
Warsaw, Masovian Voivodeship 02-776
Poland
Szpital Uniwersytecki, Oddzial Kliniczny Hematologii
Krakow, 30-688
Poland
Uniwersytecki Szpital Dzieciecy, Dzial Krwiolecznictwa
Lublin, 20-093
Poland
Uniwersytecki Szpital Dzieciecy, Dzial Krwiolecznictwa
Lublin, 20-093
Poland
Uniwersytecki Szpital Kliniczny im. J.Mikulicza-Radeckiego
Wroclaw, 50-556
Poland
Unidade De Coimbra, E.P.E. - Hospital da Universidade de Coimbra
Coimbra, 3000-459
Portugal
ULS De São José, E.P.E.- Hospital D. Estefânia
Lisbon, 1169-045
Portugal
ULS De Santo António, E.P.E. _H.Santo António_ Imunohemoterapia
Porto, 4050-342
Portugal
ULS São João, E.P.E._H.São João_Imunohemoterapia
Porto, 4200-319
Portugal
Institut Oncologic "Prof. Dr. Ion Chiricuta" Cluj Napoca
Cluj-Napoca, 400015
Romania
King Faisal Specialist Hospital & Research Centre, Riyadh
Riyadh, 12713
Saudi Arabia
Clinical Centre of Serbia, Institute for Haematology
Belgrade, 11000
Serbia
Clinical Centre of Vojvodina
Novi Sad, 21000
Serbia
Univerzitna Nemocnica Martin
Martin, 036 59
Slovakia
Vseobecna nemocnica Rimavska Sobota
Rimavská Sobota, 979 01
Slovakia
Vranovska nemocnica, a.s.
Vranov nad Topľou, 09327
Slovakia
Wits Bara Clinical Trial Site
Johannesburg, Gauteng 2013
South Africa
Charlotte Maxeke Johannesburg Academic Hospital
Parktown, Johannesburg, Gauteng 2193
South Africa
Daejeon Eulji Medical Center, Eulji University
Daejeon, 35233
South Korea
Daejeon Eulji Medical Center, Eulji University
Daejeon, 35233
South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722
South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722
South Korea
Gangdong Kyung Hee University Hospital
Seoul, 05278
South Korea
Kyung Hee University Hospital at Gangdong
Seoul, 05278
South Korea
Hospital Vall d'Hebron
Barcelona, 08035
Spain
Hospital Sant Joan de Déu
Esplugues Llobregat, 08950
Spain
Hospital Universitario La Paz
Madrid, 28046
Spain
Hospital Carlos Haya
Málaga, 29010
Spain
Hospital Regional Universitario de Málaga
Málaga, 29010
Spain
Universitätsklinik für Hämatologie
Bern, 3010
Switzerland
Pädiatrische Onkologie-Hämatologie
Lucerne, 6000
Switzerland
Zentrum für Labormedizin
Sankt Gallen, 9008
Switzerland
Universitätsspital Zürich - Klinik für Medizinische Onkologie und Hämatologie
Zurich, 8091
Switzerland
Chung Shan Medical University Hospital
Taichung, 402
Taiwan
Taichung Veterans General Hospital
Taichung, 407
Taiwan
National Taiwan University Hospital_main
Taipei, 100
Taiwan
National Taiwan University Hospital
Taipei, 100
Taiwan
Gazi University
Ankara, Beşevler/Ankara 06500
Turkey (Türkiye)
Gazi Üniversitesi Hastanesi- Hematoloji
Ankara, Beşevler/Ankara 06500
Turkey (Türkiye)
Istanbul University Oncology Institute
Capa-ISTANBUL, Capa-ISTANBUL 34093
Turkey (Türkiye)
İstanbul Üniversitesi İstanbul Tıp Fakültesi Hastanesi- Onkoloji Enstitüsü
Capa-ISTANBUL, Capa-ISTANBUL 34093
Turkey (Türkiye)
Akdeniz Üniversitesi Hastanesi- Hematoloji
Antalya, Konyaaltı/ Antalya 01010
Turkey (Türkiye)
Acıbadem Adana Hastanesi-Hematoloji
Adana, 01130
Turkey (Türkiye)
Hacettepe Universitesi
Ankara, 06100
Turkey (Türkiye)
Hacettepe Üniversitesi Hastanesi- Hematoloji
Ankara, 06100
Turkey (Türkiye)
Akdeniz Universitesi
Antalya, 01010
Turkey (Türkiye)
Ege Universitesi Tip Fakultesi
Bornova-IZMIR, 35100
Turkey (Türkiye)
Ege Üniversitesi Hastanesi- Hematoloji
Bornova-IZMIR, 35100
Turkey (Türkiye)
Trakya University
Edirne, 22030
Turkey (Türkiye)
Trakya Üniversitesi Tıp Fakültesi Hastanesi-Hematoloji
Edirne, 22030
Turkey (Türkiye)
Belfast City Hospital
Belfast, BT9 78B
United Kingdom
University Hospital of Wales - Haemophilia
Cardiff, CF14 4XW
United Kingdom
Royal Free Haemophilia Comprehensive Care Center
London, NW3 2QG
United Kingdom
Royal Free Hospital - Haemophilia
London, NW3 2QG
United Kingdom
Evelina London Children's Hospital - Haemophilia
London, SE1 7EH
United Kingdom
St Thomas' Hospital - Haemostasis and Thrombosis Centre
London, SE1 7EH
United Kingdom
Royal Hallamshire Hospital
Sheffield, S10 2JF
United Kingdom