A Research Study Looking at How Different Doses of Study Medicine (Inno8) Work in the Body of People With Haemophilia A
Recruiting now · Phase 1
Conditions studied: Haemophilia A
In brief
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.
Key facts
- Study ID
- NCT07220564
- Run by
- Novo Nordisk A/S
- People needed
- 30
- Starts
- 2025-10-23
- Expected to finish
- 2027-02-05
- Last updated by the study team
- 2026-04-24
Who can join
Age: 18 and older, up to 64. Sex: male. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- AKH - Klin. Abt. f. Haematologie u. Haemostaseologie — Vienna, Austria (enrolling)
- University of Iowa_Iowa City — Iowa City, Iowa, United States (enrolling)
- Instytut Hematologii i Transfuzjologii — Warsaw, Poland (enrolling)
- Penn State MS Hershey Med Ctr — Hershey, Pennsylvania, United States (enrolling)
- Vivantes Netzwerk für Gesundheit GmbH - Vivantes Klinikum im Friedrichshain — Berlin, Germany (enrolling)
- Hospital Vall d'Hebron — Barcelona, Spain (enrolling)
- Hospital Universitario La Paz — Madrid, Spain (enrolling)
- Hospital Regional Universitario de Málaga — Málaga, Spain (enrolling)
- Hospital Clinico Universitario de Salamanca — Salamanca, Spain (enrolling)
- Indiana Hemophilia-Thromb Ctr — Indianapolis, Indiana, United States (enrolling)
- Medizinische Hochschule Hannover - Hämatologie, Hämostaseologie, Onkologie — Hanover, Germany (enrolling)
- AOU Careggi Firenze — Florence, Italy (enrolling)
- Azienda Ospedaliera Universitaria Federico II di Napoli — Naples, Italy (enrolling)
- Uniwersytecki Szpital Kliniczny w Bialymstoku — Bialystok, Poland (enrolling)
- Royal Free Hospital - Haemophilia — London, United Kingdom (enrolling)
- Uniwersyteckie Centrum Kliniczne — Gdansk, Poland (enrolling)
- Universitätsklinik für Innere Medizin V — Innsbruck, Austria (enrolling)
- Royal Hallamshire Hospital — Sheffield, United Kingdom
- St Christopher Hosp for Child — Philadelphia, Pennsylvania, United States
- Cliniques universitaires Saint-Luc — Brussels, Belgium
- HCL - HOPITAL LOUIS PRADEL - Unité d'hémostase Clinique — Bron, France
- Universitätsklinikum Bonn - Institut für Experimentelle Hämatologie — Bonn, Germany
- Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mielęckiego Slaskiego Uniwersytetu Medycznego w Katowicach — Katowice, Poland
- Uniwersytecki Szpital Kliniczny nr 1 Klinika Hematoonkologii i Transplantacji Szpiku — Lublin, Poland
- Uniwersytecki Szpital Kliniczny W Poznaniu — Poznan, Poland
Full record on ClinicalTrials.gov
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