Phase
Condition
Hemophilia
Treatment
NNC0365-3769 (Mim8) PPX
Clinical Study ID
Ages > 12 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Informed consent obtained before any study-related activities. Study-relatedactivities are any procedures that are carried out as part of the study, includingactivities to determine suitability for the study.
Male or female with diagnosis of congenital haemophilia A of any severity based onmedical records.
Age 12 years or above at the time of signing the informed consent.
Participants treated with emicizumab once-weekly (QW), once every two weeks (Q2W),or once every four weeks (Q4W) according to the label for at least 8 weeks prior toscreening.
Participants choosing to discontinue emicizumab treatment and switch to Mim8 QW,Q2W, or once-monthly (QM) treatment for 26 weeks from start of treatment (Visit 2).
Participant and/or caregiver willingness and ability to comply with scheduled visitsand study procedures, including the completion of an electronic diary andpatient-reported outcomes (PRO) questionnaires.
Exclusion
Exclusion Criteria:
Participation (i.e., signed informed consent) in any interventional, clinical study,with the exception of emicizumab, with receipt of the last dose within 8 weeks (or 5half-lives of the investigational medicinal product [IMP], whichever is longer)before screening.
Any disorder, which in the investigator's opinion might jeopardise the participant'scompliance with the protocol or safety, including ongoing Adverse Events (AEs)associated with emicizumab.
Previous participation in this study. Participation is defined as signed informedconsent.
Known congenital or acquired coagulation disorders other than haemophilia A.
Previous or current thromboembolic disease or events (with the exception of previouscatheter associated thrombosis for which anti-thrombotic treatment is not currentlyongoing) or risk of thromboembolic disease, as evaluated by investigator.
Neutralising antibodies towards emicizumab have been detected or, for patientsadherent to emicizumab therapy, are suspected based on clinical and laboratoryassessments.
Receipt of FVIII gene therapy at any time.
Ongoing or planned immune tolerance induction therapy.
Minor or major surgery planned to take place after screening and during the 26-weektreatment period.
Known or suspected hypersensitivity to study intervention, related products, anyconstituents of the product or to other monoclonal antibodies.
Hepatic dysfunction defined as aspartate aminotransferase (AST) and/or alanineaminotransferase (ALT) greater than (>) 3 times the upper limit combined with totalbilirubin >1.5 times the upper limit measured at screening.
Renal impairment defined as estimated glomerular filtration rate (eGFR) lesser thanor equal to (≤) 30 milliliter per minute per 1.73 square meter (mL/min/1.73 m^2) forserum creatinine measured at screening.
Female who is pregnant, breast-feeding or intends to become pregnant or is ofchildbearing potential and not using highly effective contraceptive method.
Mental incapacity, unwillingness to cooperate, or a language barrier precludingadequate understanding and cooperation.
Other conditions (e.g. autoimmune disease) or laboratory abnormality that mayincrease risk of bleeding or thrombosis as evaluated by the investigator.
Study Design
Connect with a study center
Novo Nordisk Investigational Site
Innsbruck, A 6020
AustriaActive - Recruiting
Universitätsklinik für Innere Medizin V
Innsbruck, 6020
AustriaSite Not Available
Universitätsklinik für Innere Medizin V
Innsbruck 2775220, 6020
AustriaSite Not Available
AKH - Klin. Abt. f. Haematologie u. Haemostaseologie
Vienna 2761369, 1090
AustriaSite Not Available
AKH - Klin. Abt. f. Haematologie u. Haemostaseologie
Wien, 1090
AustriaSite Not Available
Novo Nordisk Investigational Site
Wien, 1090
AustriaSite Not Available
Cliniques universitaires Saint-Luc - Service Hématologie
Brussels 2800866, 1200
BelgiumSite Not Available
Cliniques universitaires Saint-Luc - Service Hématologie
Bruxelles, 1200
BelgiumSite Not Available
Novo Nordisk Investigational Site
Bruxelles, 1200
BelgiumActive - Recruiting
McMaster University
Hamilton, Ontario L8N 3Z5
CanadaSite Not Available
Novo Nordisk Investigational Site
Hamilton, Ontario L8N 3Z5
CanadaActive - Recruiting
McMaster University
Hamilton 5969782, Ontario 6093943 L8N 3Z5
CanadaSite Not Available
Hospices Civils de Lyon-Hopital Cardiologique Louis Pradel-1
Bron, 69500
FranceSite Not Available
Novo Nordisk Investigational Site
Bron, 69500
FranceActive - Recruiting
Hospices Civils de Lyon- Hopital Louis Pradel-1
Bron 3029931, 69500
FranceSite Not Available
Novo Nordisk Investigational Site
Bron Cedex, 69500
FranceSite Not Available
Novo Nordisk Investigational Site
Berlin, 10249
GermanyActive - Recruiting
Vivantes Klinikum am Friedrichshain
Berlin, 10249
GermanySite Not Available
Vivantes Klinikum am Friedrichshain - Innere Medizin - Angiologie und Hämostaseologie
Berlin, 10249
GermanySite Not Available
Vivantes Netzwerk für Gesundheit GmbH - Vivantes Klinikum im Friedrichshain
Berlin 2950159, 10249
GermanySite Not Available
Novo Nordisk Investigational Site
Bonn, 53127
GermanyActive - Recruiting
Rheinische Friedrich-Wilhelms-Universität Bonn
Bonn, 53127
GermanySite Not Available
Universitätsklinikum Bonn - Institut für Experimentelle Hämatologie
Bonn, 53127
GermanySite Not Available
Universitätsklinikum Bonn - Institut für Experimentelle Hämatologie
Bonn 2946447, 53127
GermanySite Not Available
AOU Careggi Firenze
Firenze, Toscana 50134
ItalySite Not Available
AOU Careggi Firenze
Florence 3176959, Tuscany 3165361 50134
ItalySite Not Available
Novo Nordisk Investigational Site
Firenze, 50134
ItalyActive - Recruiting
Fondazione IRCSS Ca' Granda Ospedale Maggiore Policlinico
Milan 6951411, 20122
ItalySite Not Available
Fondazione IRCSS Ca' Granda Ospedale Maggiore Policlinico
Milano, 20122
ItalySite Not Available
Novo Nordisk Investigational Site
Milano, 20122
ItalyActive - Recruiting
Azienda Ospedaliera di Rilievo Nazionale Santobono Pausilipon
Napoli, 80122
ItalySite Not Available
Novo Nordisk Investigational Site
Napoli, 80122
ItalyActive - Recruiting
Azienda Ospedaliera Santobono Pausilipon - U.S.D. Centro Regionale Pediatrico Malattie della Coagulazione
Napoli 9031661, 80122
ItalySite Not Available
Azienda Ospedaliera di Rilievo Nazionale Santobono Pausilipon
Napoli 9031661, 80122
ItalySite Not Available
Nara Medical University Hospital_Pediatrics
Nara, 634-8522
JapanSite Not Available
Novo Nordisk Investigational Site
Nara, 634-8522
JapanActive - Recruiting
Nara Medical University Hospital_Pediatrics
Nara 1855612, 634-8522
JapanSite Not Available
Gangdong Kyung Hee University Hospital
Seoul, 05278
Korea, Republic ofSite Not Available
Novo Nordisk Investigational Site
Seoul, 05278
Korea, Republic ofActive - Recruiting
Severance Hospital, Yonsei University Health System
Seoul, 03722
Korea, Republic ofSite Not Available
Novo Nordisk Investigational Site
Parktown, Johannesburg, Gauteng 2193
South AfricaActive - Recruiting
Charlotte Maxeke Johannesburg Academic Hospital
Parktown, Johannesburg, Gauteng 1085594 2193
South AfricaSite Not Available
Kyung Hee University Hospital at Gangdong
Seoul 1835848, 05278
South KoreaSite Not Available
Severance Hospital, Yonsei University Health System
Seoul 1835848, 03722
South KoreaSite Not Available
Hospital Universitario La Paz
Madrid, 28046
SpainSite Not Available
Novo Nordisk Investigational Site
Madrid, 28046
SpainActive - Recruiting
Hospital Universitario La Paz
Madrid 3117735, 28046
SpainSite Not Available
Hospital Regional Universitario de Málaga
Málaga, 29010
SpainSite Not Available
Hospital Universitario Regional de Málaga
Málaga, 29010
SpainSite Not Available
Novo Nordisk Investigational Site
Málaga, 29010
SpainActive - Recruiting
Hospital Regional Universitario de Málaga
Málaga 2514256, 29010
SpainSite Not Available
Belfast City Hospital
Belfast, BT9 78B
United KingdomSite Not Available
Novo Nordisk Investigational Site
Belfast, BT9 78B
United KingdomSite Not Available
Belfast City Hospital
Belfast 2655984, BT9 78B
United KingdomSite Not Available
Birmingham Children's Hospital
Birmingham 2655603,
United KingdomSite Not Available
Arthur Bloom Haemophilia Centre
Cardiff, CF14 4XW
United KingdomSite Not Available
Novo Nordisk Investigational Site
Cardiff, CF14 4XW
United KingdomActive - Recruiting
Arthur Bloom Haemophilia Centre
Cardiff 2653822, CF14 4XW
United KingdomSite Not Available
Novo Nordisk Investigational Site
London, NW3 2QG
United KingdomSite Not Available
Royal Free Haemophilia Comprehensive Care Center
London, NW3 2QG
United KingdomSite Not Available
Royal Free Haemophilia Comprehensive Care Centre
London, NW3 2QG
United KingdomSite Not Available
Royal Free Haemophilia Comprehensive Care Center
London 2643743, NW3 2QG
United KingdomSite Not Available
Royal Free Haemophilia Comprehensive Care Centre
London 2643743, NW3 2QG
United KingdomSite Not Available
Novo Nordisk Investigational Site
Sheffield, S10 2JF
United KingdomSite Not Available
Royal Hallamshire Hospital
Sheffield, S10 2JF
United KingdomSite Not Available
Royal Hallamshire Hospital
Sheffield 2638077, S10 2JF
United KingdomSite Not Available
Children's Hosp-Los Angeles
Los Angeles, California 90027
United StatesSite Not Available
Children's Hospital Los Angeles - Endocrinology
Los Angeles, California 90027
United StatesSite Not Available
Novo Nordisk Investigational Site
Los Angeles, California 90027
United StatesSite Not Available
Children's Hospital Los Angeles - Endocrinology
Los Angeles 5368361, California 5332921 90027
United StatesSite Not Available
UC Davis Medical Center
Sacramento 5389489, California 5332921 95817
United StatesSite Not Available
Novo Nordisk Investigational Site
Aurora, Colorado 80045
United StatesActive - Recruiting
UC Denver Hemoph & Thrombo Ctr
Aurora, Colorado 80045
United StatesSite Not Available
UC Denver Hemoph & Thrombo Ctr
Aurora 5412347, Colorado 5417618 80045
United StatesSite Not Available
Novo Nordisk Investigational Site
Tampa, Florida 33607
United StatesActive - Recruiting
St Joseph's Children's Hospita
Tampa, Florida 33607
United StatesSite Not Available
St Joseph's Hospital Foundation
Tampa 4174757, Florida 4155751 33607
United StatesSite Not Available
Augusta Univ/Childrens Hosp-GA
Augusta 4180531, Georgia 4197000 30912
United StatesSite Not Available
Rush University Med. Cntr
Chicago 4887398, Illinois 4896861 60612
United StatesSite Not Available
Novo Nordisk Investigational Site
Iowa City, Iowa 52242
United StatesActive - Recruiting
University of Iowa_Iowa City
Iowa City, Iowa 52242
United StatesSite Not Available
University of Iowa_Iowa City
Iowa City 4862034, Iowa 4862182 52242
United StatesSite Not Available
Central Michigan University
Detroit, Michigan 48201
United StatesSite Not Available
Novo Nordisk Investigational Site
Detroit, Michigan 48201
United StatesSite Not Available
Michigan State University
East Lansing, Michigan 48824
United StatesSite Not Available
Novo Nordisk Investigational Site
East Lansing, Michigan 48824
United StatesActive - Recruiting
Novo Nordisk Investigational Site
Mount Pleasant, Michigan 48859
United StatesSite Not Available
Central Michigan University
Detroit 4990729, Michigan 5001836 48201
United StatesSite Not Available
Michigan State University
East Lansing 4991640, Michigan 5001836 48824
United StatesSite Not Available
Novo Nordisk Investigational Site
Cleveland, Ohio 44106
United StatesActive - Recruiting
Univ Hosp Cleveland Med Ctr
Cleveland, Ohio 44106
United StatesSite Not Available
Univ Hosp Cleveland Med Ctr
Cleveland 5150529, Ohio 5165418 44106
United StatesSite Not Available
Nationwide Children's Hospital
Columbus 4509177, Ohio 5165418 43205
United StatesSite Not Available
Novo Nordisk Investigational Site
Hershey, Pennsylvania 17033-2360
United StatesActive - Recruiting
Penn State MS Hershey Med Ctr
Hershey, Pennsylvania 17033-2360
United StatesSite Not Available
Penn State MS Hershey Med Ctr
Hershey 5193342, Pennsylvania 6254927 17033-2360
United StatesSite Not Available
Novo Nordisk Investigational Site
Nashville, Tennessee 37212
United StatesActive - Recruiting
Vanderbilt U Med Ctr_Nashville
Nashville, Tennessee 37212
United StatesSite Not Available
Vanderbilt U Med Ctr_Nashville
Nashville 4644585, Tennessee 4662168 37212
United StatesSite Not Available

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