Testing denecimig for acquired haemophilia A in adults
Tests whether denecimig is safe and works for adults with acquired haemophilia A.
Plain-language title generated from the registry record
Registry title: A Research Study Investigating Denecimig (Mim8) in Adults With Acquired Haemophilia A
Key facts
- Where
- Berlin, Bonn, Hanover, Leipzig, and Regensburg, GermanySee the 5 sites
- Phase
- Phase 3
Where in Germany
- Vivantes Netzwerk fuer Gesundheit GmbHBerlin, GermanyTaking people
- Universitaetsklinikum Bonn AöRBonn, GermanyTaking people
- Medizinische Hochschule HannoverHanover, GermanyTaking people
- Universitaetsklinikum Leipzig AorLeipzig, GermanyTaking people
- Universitaetsklinikum Regensburg AöRRegensburg, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Novo Nordisk A/S
- Trial code
- NCT07830732EU 2026-525529-19-00
- Record updated
- 28 October 2026
- Original description
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).Read full original descriptionShow less
A Multinational, Open-label Study to Investigate Efficacy and Safety of Denecimig (Mim8) in Adults With Acquired Haemophilia A
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).
Inclusion: 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: 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; 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); 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; Life expectancy <3 months at the time of screening, as evaluated by the investigator.