Status:
RECRUITING
A Research Study Looking at How Different Doses of Study Medicine (Inno8) Work in the Body of People With Haemophilia A
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Haemophilia A
Eligibility:
MALE
18-64 years
Phase:
PHASE1
Brief Summary
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 haemophil...
Eligibility Criteria
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.
- Body mass index ≥30.0 kilogram per square meter (kg/m\^2).
- 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.
- Ongoing or planned immune tolerance induction therapy.
- Presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs and/or nutrients, as judged by the investigator.
Key Trial Info
Start Date :
October 23 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 21 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT07220564
Start Date
October 23 2025
End Date
December 21 2026
Last Update
December 30 2025
Active Locations (18)
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1
Indiana Hemophilia-Thromb Ctr
Indianapolis, Indiana, United States, 46260
2
University of Iowa_Iowa City
Iowa City, Iowa, United States, 52242
3
Penn State MS Hershey Med Ctr
Hershey, Pennsylvania, United States, 17033-2360
4
Universitätsklinik für Innere Medizin V
Innsbruck, Austria, 6020