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A Research Study Investigating Denecimig (Mim8) in Adults With Acquired Haemophilia A
84 patients around the world
Available in Argentina, Brazil, United States
Novo Nordisk A/S
5Research sites
84Patients around the world
This study is for people with
Hemophilia
Hemophilia a
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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 participants (sex assigned at birth, inclusive of all gender identities) newly diagnosed with acquired haemophilia A (AHA) prior to signing the informed consent form, with AHA diagnosis (FVIII activity lesser than (<) 50 percentage (%) and FVIII inhibitors greater than (>) 0.6 Bethesda units [BU]) confirmed at screening.Treatment-requiring bleed(s) due to AHA from diagnosis and until screening.The participant is capable of following study procedures and able to seek medical attention when needed.
- Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate and highly effective contraceptive method.Previous or current thromboembolic disease or eventsa (with the exception of previous catheter associated thrombosis for which anti-thrombotic treatment is not currently ongoing) or risk of thromboembolic disease.Life expectancy <3 months at the time of screening, as evaluated by the investigator.Therapy with immunosuppressive or immune modulating drugs for treatment of AHA (other than less than or equal to (≤) 2 days of prednisolone (or equivalent) for AHA at a dose ≤100 mg per day) prior to screening.Immunosuppressive therapy (IST) initiated prior to AHA diagnosis for other medical conditions (e.g., other autoimmune disorders) is permitted, provided it was initiated greater than or equal to (≥) 6 months prior to screening, has been maintained at a stable dose and regimen since initiation, and is expected to remain at a stable dose and regimen at least during the main treatment period (Weeks 0-12).
Sites
HEMORIO Instituto Nacional de Hematología
Hospital Samaritano de São Paulo
Hospital de Clínicas - Universidade Estadual de Campinas - UNICAMP
Hospital das Clínicas de Ribeirão Preto
Hospital das Clínicas da Faculdade de Medicina da São Paulo - FMUSP
StudyFRONTIERAHA
SponsorNovo Nordisk A/S
Study typeInterventional
Conditions
Hemophilia a
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07830732
