A Research Study Investigating Mim8 in Adults and Adolescents With Haemophilia A With or Without Inhibitors
Launched by NOVO NORDISK A/S · Sep 13, 2021
Trial Information
Current as of May 15, 2025
Completed
Keywords
ClinConnect Summary
This clinical trial is studying a new medicine called Mim8 for adults and adolescents with Haemophilia A, which is a condition that leads to bleeding problems. Mim8 is designed to help prevent bleeding by replacing a missing protein in the blood that is crucial for clotting. The study will compare how well Mim8 works against other treatments in patients who either have or do not have inhibitors, which are proteins that can interfere with treatment effectiveness. Participants will receive Mim8 through an injection in their stomach once a week or once a month, depending on their previous treatment.
To join this study, participants need to be at least 12 years old and weigh at least 30 kg. They should have been treated for Haemophilia A within the last 26 weeks and have experienced bleeding episodes. The trial will last between 12 to 29 months, and participants will have around 12 to 17 visits to the clinic during this time. It’s important for participants to be willing to keep track of their experiences and attend all scheduled visits. If you or someone you know might be interested in participating, please talk to a healthcare provider for more details.
Gender
ALL
Eligibility criteria
- 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 participants with diagnosis of congenital haemophilia A of any severity based on medical records.
- • 3. Participant has been prescribed treatment with factor VIII concentrates or bypassing agent in the last 26 weeks prior to screening.
- • 4. Age above or equal to 12 years at the time of signing informed consent.
- • 5. Body weight greater than or equal to 30 kg.
- • 6. Applicable to participants treated with on-demand/no prophylaxis prior to enrolment: ≥5 bleeds in the last 26 weeks prior to screening visit, for which factor VIII concentrates or bypassing agent has been prescribed.
- • 7. Applicable to participants with FVIII activity ≥1% who are on prophylactic treatment: ≥1 bleed in the last 26 weeks prior to screening visit, for which factor VIII concentrates or bypassing agent has been prescribed.
- • 8. Willingness and ability to comply with scheduled visits and study procedures, including the completion of diary and patient-reported outcomes questionnaires.
- Exclusion Criteria:
- • 1. Previous participation in this study. Participation is defined as signed informed consent.
- • 2. 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 randomisation.
- • 3. 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 randomisation, for participants not included in the run-in.
- • 4. Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method. Breast feeding is allowed only during the run-in period.
- • 5. 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.
- • 6. Known or suspected hypersensitivity to trial product(s), any constituents of the product or to related products.
- • 7. Receipt of gene therapy at any given time point.
- • 8. Ongoing or planned immune tolerance induction (ITI) therapy.
- • 9. Major surgery planned to take place after screening.
- • 10. Known congenital or acquired coagulation disorders other than haemophilia A.
- • 11. Hepatic dysfunction defined as aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) above 3 times the upper limit combined with total bilirubin above1.5 times the upper limit measured at screening.
- • 12. Renal impairment defined as estimated Glomerular Filtration Rate (eGFR) below or equal to 30 ml/min/1.73 m\^2 for serum creatinine measured at screening.
- • 13. Previous or current thromboembolic disease or events (with the exception of previous catheter-associated thrombosis for which anti-thrombotic treatment is not currently ongoing) or risk of thromboembolic disease, as evaluated by investigator.
- • 14. Mental incapacity, unwillingness to cooperate, or a language barrier precluding adequate understanding and cooperation.
- • 15. Other conditions (e.g., autoimmune disease) or laboratory abnormality that may increase risk of bleeding or thrombosis as evaluated by the investigator.
About Novo Nordisk A/S
Novo Nordisk A/S is a global healthcare company headquartered in Denmark, specializing in the research, development, manufacturing, and marketing of innovative pharmaceuticals, particularly in the fields of diabetes care, obesity treatment, and hormone replacement therapies. With a strong commitment to improving patient outcomes, Novo Nordisk invests significantly in clinical trials to advance scientific knowledge and develop effective therapies. The company is dedicated to sustainability and ethical practices, striving to deliver high-quality healthcare solutions while addressing the evolving needs of patients worldwide. Through collaboration and innovation, Novo Nordisk aims to lead the way in transforming diabetes and other chronic diseases into manageable conditions.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Ann Arbor, Michigan, United States
Amsterdam, , Netherlands
Madrid, , Spain
Columbus, Ohio, United States
Milwaukee, Wisconsin, United States
Barcelona, , Spain
Taipei, , Taiwan
Toronto, Ontario, Canada
Miami, Florida, United States
Iowa City, Iowa, United States
Ann Arbor, Michigan, United States
Dayton, Ohio, United States
Taichung City, , Taiwan
Tampa, Florida, United States
Barcelona, , Spain
Aurora, Colorado, United States
Indianapolis, Indiana, United States
Lille, , France
Paris, , France
Madrid, , Spain
Bornova Izmir, , Turkey
Capa Istanbul, , Turkey
Zürich, , Switzerland
Firenze, , Italy
Amsterdam, , Netherlands
Utrecht, , Netherlands
Taipei, , Taiwan
Hamilton, Ontario, Canada
København ø, , Denmark
Nantes Cedex 1, , France
Paris, , France
Rennes, , France
Krakow, , Poland
Bern, , Switzerland
Vellore, Tamil Nadu, India
Bruxelles, , Belgium
Leuven, , Belgium
Cleveland, Ohio, United States
Columbus, Ohio, United States
Edegem, , Belgium
Wien, , Austria
Ankara, , Turkey
Mumbai, Maharashtra, India
Taichung City, , Taiwan
Martin, , Slovakia
Málaga, , Spain
Martin, , Slovakia
Moscow, , Russian Federation
Tel Hashomer, , Israel
Adana, , Turkey
Antalya, , Turkey
Atlanta, Georgia, United States
Petrozavodsk, , Russian Federation
Johannesburg, Gauteng, South Africa
London, , United Kingdom
Hangzhou, Zhejiang, China
London, , United Kingdom
Cardiff, , United Kingdom
Hangzhou, Zhejiang, China
Rimavska Sobota, , Slovakia
Ludhiana, Punjab, India
Bucuresti, , Romania
Phoenix, Arizona, United States
Toronto, Ontario, Canada
Le Kremlin Bicetre, , France
Bonn, , Germany
Changsha, Hunan, China
Berlin, , Germany
Belgrade, , Serbia
Novi Sad, , Serbia
Novi Sad, , Serbia
Bron Cedex, , France
Oxford, , United Kingdom
Seoul, , Korea, Republic Of
Wroclaw, , Poland
Kota Kinabalu, , Malaysia
Hamilton, Ontario, Canada
Omaha, Nebraska, United States
Suzhou, Jiangsu, China
Wuhan, Hubei, China
New Orleans, Louisiana, United States
Philadelphia, Pennsylvania, United States
Aichi, , Japan
Selangor Darul Ehsan, , Malaysia
Savannah, Georgia, United States
Beijing, Beijing, China
Guangzhou, Guangdong, China
Tianjing, Tianjin, China
Tokyo, , Japan
Vilnius, , Lithuania
Lublin, , Poland
Krasnodar, , Russian Federation
Coimbra, , Portugal
Innsbruck, , Austria
Jinan, Shandong, China
Hershey, Pennsylvania, United States
Rennes, , France
Kunming, Yunnan, China
Seoul, , Korea, Republic Of
Milwaukee, Wisconsin, United States
Wuhan, Hubei, China
Kunming, Yunnan, China
Porto, , Portugal
Tochigi, , Japan
Riga, , Latvia
Mörfelden Walldorf, , Germany
Saitama, , Japan
Parktown, Johannesburg, Gauteng, South Africa
Surat, Gujarat, India
Las Vegas, Nevada, United States
Seoul, , Korea, Republic Of
Adana, , Turkey
Vilnius, , Lithuania
Taichung City, , Taiwan
Porto, , Portugal
Suzhou, Jiangsu, China
Surat, Gujarat, India
Ludhiana, Punjab, India
Bonn, , Germany
Innsbruck, , Austria
Daejeon, , Korea, Republic Of
Kitakyusyu Shi, Fukuoka, , Japan
Daejeon, , Korea, Republic Of
Saint Petersburg, , Russian Federation
Las Vegas, Nevada, United States
Parktown, Johannesburg, Gauteng, South Africa
Taichung City, , Taiwan
Praha 2, , Czechia
Okinawa, , Japan
Cardiff, , United Kingdom
Milano, , Italy
Changsha, Hunan, China
Bucuresti, , Romania
Krasnodar, , Russian Federation
Chengdu, Sichuan, China
Los Angeles, California, United States
Dublin, , Ireland
Kaunas, , Lithuania
Riyadh, , Saudi Arabia
Vranov Nad Toplou, , Slovakia
St. Gallen, , Switzerland
Capa Istanbul, , Turkey
Ankara, Beşevler/Ankara, Turkey
Noida, Uttar Pradesh, India
Merida, , Mexico
Wroclaw, Dolnoslaskie, Poland
Craiova, Dolj, Romania
Cluj Napoca, , Romania
Timisoara, , Romania
Rimavska Sobota, , Slovakia
St. Gallen, , Switzerland
Craiova, Dolj, Romania
Ranipet, Tamil Nadu, India
Tianjin, Tianjin, China
Dublin, Leinster, Ireland
Bron Cedex, , France
Chengdu, Sichuan, China
Ji'nan, Shandong, China
Kota Kinabalu, Sabah, Malaysia
Hangzhou, Zhejiang, China
Le Kremlin Bicetre Cedex, , France
Coimbra, , Portugal
Kraków, Małopolskie, Poland
Bron, , France
Chengdu, Sichuan, China
Krakow, Małopolskie, Poland
Leuven, , Belgium
Dublin, Leinster, Ireland
Mumbai, Maharashtra, India
Los Angeles, California, United States
Johannesburg, Gauteng, South Africa
Philadelphia, Pennsylvania, United States
Ji'nan, Shandong, China
Cleveland, Ohio, United States
Phoenix, Arizona, United States
Los Angeles, California, United States
Aurora, Colorado, United States
Miami, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Savannah, Georgia, United States
Indianapolis, Indiana, United States
Iowa City, Iowa, United States
New Orleans, Louisiana, United States
Omaha, Nebraska, United States
Dayton, Ohio, United States
Hershey, Pennsylvania, United States
Innsbruck, , Austria
Wien, , Austria
Bruxelles, , Belgium
Edegem, , Belgium
Beijing, Beijing, China
Guangzhou, Guangdong, China
Tianjin, Tianjin, China
Praha 2, , Czechia
København ø, , Denmark
Bron Cedex, , France
Bron, , France
Le Kremlin Bicetre Cedex, , France
Lille, , France
Nantes Cedex 1, , France
Berlin, , Germany
Mörfelden Walldorf, , Germany
Ranipet, Tamil Nadu, India
Noida, Uttar Pradesh, India
Dublin, , Ireland
Tel Hashomer, , Israel
Firenze, , Italy
Milano, , Italy
Aichi, , Japan
Kitakyusyu Shi, Fukuoka, , Japan
Okinawa, , Japan
Saitama, , Japan
Tochigi, , Japan
Tochigi, , Japan
Tokyo, , Japan
Tokyo, , Japan
Tokyo, , Japan
Riga, , Latvia
Riga, , Latvia
Kaunas, , Lithuania
Vilnius, , Lithuania
Kota Kinabalu, Sabah, Malaysia
Selangor Darul Ehsan, , Malaysia
Merida, , Mexico
Utrecht, , Netherlands
Wroclaw, Dolnoslaskie, Poland
Krakow, Małopolskie, Poland
Kraków, Małopolskie, Poland
Lublin, , Poland
Coimbra, , Portugal
Porto, , Portugal
Cluj Napoca, , Romania
Timisoara, , Romania
Moscow, , Russian Federation
Moscow, , Russian Federation
Petrozavodsk, , Russian Federation
Saint Petersburg, , Russian Federation
Riyadh, , Saudi Arabia
Belgrade, , Serbia
Novi Sad, , Serbia
Martin, , Slovakia
Rimavska Sobota, , Slovakia
Vranov Nad Toplou, , Slovakia
Málaga, , Spain
Bern, , Switzerland
St. Gallen, , Switzerland
Zürich, , Switzerland
Ankara, Beşevler/Ankara, Turkey
Antalya, , Turkey
Bornova Izmir, , Turkey
Capa Istanbul, , Turkey
London, , United Kingdom
Oxford, , United Kingdom
Hangzhou, Zhejiang, China
Nantes, , France
Kitakyusyu Shi, Fukuoka, , Japan
Vranov Nad Toplou, , Slovakia
Porto, , Portugal
Frankfurt Am Main, , Germany
Los Angeles, California, United States
Zürich, , Switzerland
Bonn, , Germany
Ranipet, Tamil Nadu, India
Berlin, , Germany
Tianjin, Tianjin, China
Porto, , Portugal
Wuhan, Hubei, China
Riga, , Latvia
Riga, , Latvia
Coimbra, , Portugal
Coimbra, , Portugal
Patients applied
Trial Officials
Clinical Transparency (dept. 2834)
Study Director
Novo Nordisk A/S
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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