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A Research Study Investigating Denecimig (Mim8) in Adults With Acquired Haemophilia A

RecruitingPhase 3Ages 18 Years - anyAllNovo Nordisk A/S
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In plain words

What the trial is, and whether it could suit you

The purpose of this study is to find out if denecimig is safe and effective for treating people who have acquired haemophilia A. Participants will be in this study for up to around 1 year and 5 months (73 week).

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * 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. Exclusion Criteria: * 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 (โ‰ค) 2 days of prednisolone (or equivalent) for AHA at a dose โ‰ค100 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 (โ‰ฅ) 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).
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What it tests

  • Denecimig
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Where

83 sites
University of Iowa_Iowa City
Iowa City, United States
Tulane University School of Medicine
Metairie, United States
University of Minnesota
Minneapolis, United States
Mayo Clinic
Rochester, United States
Washington University
St Louis, United States
University of North Carolina
Chapel Hill, United States
Duke University_Durham
Durham, United States
University of Oklahoma Health
Oklahoma City, United States

โ€ฆand 75 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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