Menu
Recruiting NCT07220564

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

Phase I Interventional Haemophilia A

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: NNC0442-0344 A.
Who it may be relevant to
Registry conditions: Haemophilia A. Basic parameters: 18 years — 64 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Austria, Belgium, France, Germany +7
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Peroral Doses of Inno8 in People With Haemophilia A

Overview

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.

Interventions

  • Drug NNC0442-0344 A
    NNC0442-0344 A will be administered orally.

Primary outcome measures

  • Number of treatment emergent adverse events [Time frame: From time of dosing (Day 1) to end of follow-up (Day 46)]
Secondary outcome measures (10)
  • Change in D-dimer [Time frame: From time of dosing (Day 1) to end of follow-up (Day 46)]
  • Change in prothrombin fragment 1 and 2 [Time frame: From time of dosing (Day 1) to end of follow-up (Day 46)]
  • Change in fibrinogen [Time frame: From time of dosing (Day 1) to end of follow-up (Day 46)]
  • Change in platelets [Time frame: From time of dosing (Day 1) to end of follow-up (Day 46)]
  • Occurrence of anti-Inno8 antibodies [Time frame: From time of dosing (Day 1) to end of follow-up (Day 46)]
  • Cmax: the maximum concentration of Inno8 after multiple doses [Time frame: From Day 10 to Day 11]
  • Tmax: the time to Cmax after last multiple dose [Time frame: From day 10 to Day 11]
  • Tmax: the time to Cmax after first dose [Time frame: From Day 1 to Day 2]
  • AUC: the area under the Inno8 concentration-time curve in the dosing interval after multiple doses [Time frame: From Day 10 to Day 11]
  • Maximum thrombin generation (peak height) [Time frame: From Day 10 to Day 11]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Poland · 6 centers
  • Uniwersytecki Szpital Kliniczny w Bialymstoku — Bialystok
  • Uniwersyteckie Centrum Kliniczne — Gdansk
  • Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mielęckiego Slaskiego Uniwersytetu Me — Katowice
  • Uniwersytecki Szpital Kliniczny nr 1 Klinika Hematoonkologii i Transplantacji Szpiku — Lublin
  • Uniwersytecki Szpital Kliniczny W Poznaniu — Poznan
  • Instytut Hematologii i Transfuzjologii — Warsaw
United States · 5 centers
  • UC Denver Hemoph & Thrombo Ctr — Aurora
  • Indiana Hemophilia-Thromb Ctr — Indianapolis
  • University of Iowa_Iowa City — Iowa City
  • Penn State MS Hershey Med Ctr — Hershey
  • St Christopher Hosp for Child — Philadelphia
Spain · 5 centers
  • Hospital Vall d'Hebron — Barcelona
  • Hospital Universitario La Paz — Madrid
  • Hospital Regional Universitario de Málaga — Málaga
  • Hospital Clinico Universitario de Salamanca — Salamanca
  • Hospital La Fe - Hemostasia y Trombosis — Valencia
Germany · 3 centers
  • Vivantes Netzwerk für Gesundheit GmbH - Vivantes Klinikum im Friedrichshain — Berlin
  • Universitätsklinikum Bonn - Institut für Experimentelle Hämatologie — Bonn
  • Medizinische Hochschule Hannover - Hämatologie, Hämostaseologie, Onkologie — Hanover
United Kingdom · 3 centers
  • Queen Elizabeth Hospital, Birmingham - Haemophilia — Birmingham
  • Royal Free Hospital - Haemophilia — London
  • Royal Hallamshire Hospital — Sheffield
Austria · 2 centers
  • Universitätsklinik für Innere Medizin V — Innsbruck
  • AKH - Klin. Abt. f. Haematologie u. Haemostaseologie — Vienna
Italy · 2 centers
  • AOU Careggi Firenze — Florence
  • Azienda Ospedaliera Universitaria Federico II di Napoli — Naples
Portugal · 2 centers
  • ULS De Santo António, E.P.E. _H.Santo António_ Imunohemoterapia — Porto
  • ULS São João, E.P.E._H.São João_Imunohemoterapia — Porto
Sweden · 2 centers
  • Skåne US - Koagulationsmottagning — Malmö
  • KS Solna - Koagulationsmottagningen — Solna
Belgium · 1 center
  • Cliniques universitaires Saint-Luc — Brussels
France · 1 center
  • HCL - HOPITAL LOUIS PRADEL - Unité d'hémostase Clinique — Bron
Switzerland · 1 center
  • Zentrum für Labormedizin — Sankt Gallen

Identifiers

NCT: NCT07220564 · NN7442-8454 · U1111-1317-4366 · 2025-520490-38

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗