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
- Aarhus N, DenmarkSee the site
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults newly diagnosed with acquired haemophilia A who have had a bleed that needed treatment.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Newly diagnosed acquired haemophilia A (AHA), confirmed at screening (FVIII activity <50% and FVIII inhibitors >0.6 Bethesda units), with a bleed that needed treatment.
- Earlier treatment
- No immune-suppressing or immune-changing drugs for AHA before screening, except up to 2 days of prednisolone (or equivalent) at 100 mg per day or less. Immune-suppressing treatment for other conditions is allowed if started at least 6 months before screening and kept stable.
- Biomarker or test result
- FVIII activity below 50% and FVIII inhibitors above 0.6 Bethesda units (BU), confirmed at screening.
Main reasons for not taking part
- Pregnant, breast-feeding or planning pregnancy, or able to become pregnant and not using highly effective contraception
- Past or current blood clot disease, or risk of it (except an earlier catheter-related clot with no current anti-clot treatment)
- Life expectancy under 3 months
- Immune-suppressing treatment for AHA before screening (beyond the short prednisolone allowance)
Read by machine on 12 November 2026.
Where in Denmark
- Region MidtjyllandAarhus N, DenmarkTaking 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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial 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.