Testing Inno8 doses in adults with haemophilia A
Tests how different doses of Inno8 work in adults with haemophilia A.
Plain-language title generated from the registry record
Registry title: A Research Study Looking at How Different Doses of Study Medicine (Inno8) Work in the Body of People With Haemophilia A
Key facts
- Where
- Sint-Lambrechts-Woluwe, BelgiumSee the site
- Phase
- Phase 1
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 men aged 18 to 64 with congenital haemophilia A, with or without FVIII inhibitors. It tests different doses of the study medicine Inno8 for safety and how it works in the body.
- Age
- 18 to 64 years (both inclusive)
- Sex
- Men only
- Disease stage
- Congenital haemophilia A with factor VIII (FVIII) activity of 15% or less, with or without FVIII inhibitors, based on medical records
- Earlier treatment
- Cannot have had any preventive (prophylactic) treatment for haemophilia A within 5 half-lives of the medicine before screening. Cannot have ongoing or planned immune tolerance induction therapy.
- Biomarker or test result
- FVIII activity of 15% or less
Main reasons for not taking part
- Body weight under 45 kg (99 lb) or body mass index of 30.0 kg/m^2 or more
- Higher risk of blood clots, such as a personal or first-degree relative history of unprovoked deep vein thrombosis
- Signs or diagnosis of venous or arterial thromboembolic disease
- Any other known bleeding or clotting disorder besides haemophilia A
- Stomach or bowel disorders that may affect how drugs or nutrients are absorbed
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 64 years old?
Source: NCT07220564, who can take part
Where in Belgium
- Cliniques Universitaires Saint-LucSint-Lambrechts-Woluwe, BelgiumNot yet recruiting
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
- NCT07220564EU 2025-520490-38-00
- Record updated
- 18 September 2026
- Original description
This study will test how different doses of study medicine (Inno8) work in the bodies of people with haemophilia A. The purpose of the study is to see if Inno8 is safe to use for people with haemophilia A. The study medicine is a new medicine that cannot yet be prescribed by doctors. The study will last for about 11 weeks.Read full original descriptionShow less
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Peroral Doses of Inno8 in People With Haemophilia A
This study will test how different doses of study medicine (Inno8) work in the bodies of people with haemophilia A. The purpose of the study is to see if Inno8 is safe to use for people with haemophilia A. The study medicine is a new medicine that cannot yet be prescribed by doctors. The study will last for about 11 weeks.
Inclusion: Male; Age 18-64 years (both inclusive) at the time of signing the informed consent; Body weight greater than or equal to (≥) 45 kilograms (kgs); Diagnosis of congenital haemophilia A with factor VIII (FVIII) activity less than or equal to (≤) 15 percentage (%) with or without FVIII inhibitors, based on medical records.
Exclusion: Current or prior exposure to any prophylactic treatment for haemophilia A within 5 half-lives of the medicinal product by the time of screening; Ongoing or planned immune tolerance induction therapy; Increased risk of thrombosis, e.g. known history of personal or first-degree relative(s) with unprovoked deep vein thrombosis; Any clinical signs or established diagnosis of venous or arterial thromboembolic disease; Any known coagulation disorders other than haemophilia A; Presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs and/or nutrients, as judged by the investigator; Body mass index ≥30.0 kilogram per square meter (kg/m\^2).