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A Research Study Looking at How Different Doses of Study Medicine (Inno8) Work in the Body of People With Haemophilia A

RecruitingPhase 1Ages 18 Years - 64 YearsMaleNovo Nordisk A/S
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In plain words

What the trial is, and whether it could suit you

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.

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

📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * 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.
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What it tests

  • NNC0442-0344 A
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Where

33 sites
UC Denver Hemoph & Thrombo Ctr
Aurora, United States
Indiana Hemophilia-Thromb Ctr
Indianapolis, United States
University of Iowa_Iowa City
Iowa City, United States
Penn State MS Hershey Med Ctr
Hershey, United States
St Christopher Hosp for Child
Philadelphia, United States
Universitätsklinik für Innere Medizin V
Innsbruck, Austria
AKH - Klin. Abt. f. Haematologie u. Haemostaseologie
Vienna, Austria
Cliniques universitaires Saint-Luc
Brussels, Belgium

…and 25 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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