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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
NNC0442-0344 A will be administered orally.
UC Denver Hemoph & Thrombo Ctr
Aurora, Colorado, United States
Number of treatment emergent adverse events
Measured as count of events.
Time frame: From time of dosing (Day 1) to end of follow-up (Day 46)
Change in D-dimer
Measured as absolute and percentage (%).
Time frame: From time of dosing (Day 1) to end of follow-up (Day 46)
Change in prothrombin fragment 1 and 2
Measured as absolute and %.
Time frame: From time of dosing (Day 1) to end of follow-up (Day 46)
Change in fibrinogen
Measured as absolute and %.
Time frame: From time of dosing (Day 1) to end of follow-up (Day 46)
Change in platelets
Measured as absolute and %.
Time frame: From time of dosing (Day 1) to end of follow-up (Day 46)
Occurrence of anti-Inno8 antibodies
Measured as count.
Time frame: From time of dosing (Day 1) to end of follow-up (Day 46)
Cmax: the maximum concentration of Inno8 after multiple doses
Measured as nanograms per millilitre (ng/mL).
Time frame: From Day 10 to Day 11
Tmax: the time to Cmax after last multiple dose
Measured as hours.
Time frame: From day 10 to Day 11
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Indiana Hemophilia-Thromb Ctr
Indianapolis, Indiana, United States
RECRUITINGUniversity of Iowa_Iowa City
Iowa City, Iowa, United States
RECRUITINGPenn State MS Hershey Med Ctr
Hershey, Pennsylvania, United States
RECRUITINGSt Christopher Hosp for Child
Philadelphia, Pennsylvania, United States
NOT_YET_RECRUITINGUniversitätsklinik für Innere Medizin V
Innsbruck, Austria
RECRUITINGAKH - Klin. Abt. f. Haematologie u. Haemostaseologie
Vienna, Austria
RECRUITINGVivantes Netzwerk für Gesundheit GmbH - Vivantes Klinikum im Friedrichshain
Berlin, Germany
RECRUITINGUniversitätsklinikum Bonn - Institut für Experimentelle Hämatologie
Bonn, Germany
NOT_YET_RECRUITINGMedizinische Hochschule Hannover - Hämatologie, Hämostaseologie, Onkologie
Hanover, Germany
RECRUITING...and 12 more locations
Tmax: the time to Cmax after first dose
Measured as hours.
Time frame: From Day 1 to Day 2
AUC: the area under the Inno8 concentration-time curve in the dosing interval after multiple doses
Measured as nanograms\*day per millilitre (ng\*day/mL).
Time frame: From Day 10 to Day 11
Maximum thrombin generation (peak height)
Measured as nanomolar (nM).
Time frame: From Day 10 to Day 11