Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1317-4366 | Other Identifier | Universal Trial Number | |
| 2025-520490-38 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Participants will receive oral dose of NNC0442-0344 A. |
|
| Cohort 2 | Experimental | Participants will receive oral dose of NNC0442-0344 A. |
|
| Cohort 3 | Experimental | Participants will receive oral dose of NNC0442-0344 A. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC0442-0344 A | Drug | NNC0442-0344 A will be administered orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of treatment emergent adverse events | Measured as count of events. | From time of dosing (Day 1) to end of follow-up (Day 46) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in D-dimer | Measured as absolute and percentage (%). | From time of dosing (Day 1) to end of follow-up (Day 46) |
| Change in prothrombin fragment 1 and 2 | Measured as absolute and %. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Novo Nordisk | Contact | (+1) 866-867-7178 | clinicaltrials@novonordisk.com |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 2834) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC Denver Hemoph & Thrombo Ctr | Not yet recruiting | Aurora | Colorado | 80045 | United States | |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| From time of dosing (Day 1) to end of follow-up (Day 46) |
| Change in fibrinogen | Measured as absolute and %. | From time of dosing (Day 1) to end of follow-up (Day 46) |
| Change in platelets | Measured as absolute and %. | From time of dosing (Day 1) to end of follow-up (Day 46) |
| Occurrence of anti-Inno8 antibodies | Measured as count. | 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). | From Day 10 to Day 11 |
| Tmax: the time to Cmax after last multiple dose | Measured as hours. | From day 10 to Day 11 |
| Tmax: the time to Cmax after first dose | Measured as hours. | 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). | From Day 10 to Day 11 |
| Maximum thrombin generation (peak height) | Measured as nanomolar (nM). | From Day 10 to Day 11 |
| Indiana Hemophilia-Thromb Ctr |
| Recruiting |
| Indianapolis |
| Indiana |
| 46260 |
| United States |
| University of Iowa_Iowa City | Recruiting | Iowa City | Iowa | 52242 | United States |
| Penn State MS Hershey Med Ctr | Recruiting | Hershey | Pennsylvania | 17033-2360 | United States |
| St Christopher Hosp for Child | Not yet recruiting | Philadelphia | Pennsylvania | 19134 | United States |
| Universitätsklinik für Innere Medizin V | Recruiting | Innsbruck | 6020 | Austria |
| AKH - Klin. Abt. f. Haematologie u. Haemostaseologie | Recruiting | Vienna | 1090 | Austria |
| Cliniques universitaires Saint-Luc | Not yet recruiting | Brussels | 1200 | Belgium |
| HCL - HOPITAL LOUIS PRADEL - Unité d'hémostase Clinique | Not yet recruiting | Bron | 69500 | France |
| Vivantes Netzwerk für Gesundheit GmbH - Vivantes Klinikum im Friedrichshain | Recruiting | Berlin | 10249 | Germany |
| Universitätsklinikum Bonn - Institut für Experimentelle Hämatologie | Not yet recruiting | Bonn | 53127 | Germany |
| Medizinische Hochschule Hannover - Hämatologie, Hämostaseologie, Onkologie | Recruiting | Hanover | 30625 | Germany |
| AOU Careggi Firenze | Recruiting | Florence | 50134 | Italy |
| Azienda Ospedaliera Universitaria Federico II di Napoli | Recruiting | Naples | 80131 | Italy |
| Uniwersytecki Szpital Kliniczny w Bialymstoku | Recruiting | Bialystok | 15-276 | Poland |
| Uniwersyteckie Centrum Kliniczne | Recruiting | Gdansk | 80-214 | Poland |
| Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mielęckiego Slaskiego Uniwersytetu Medycznego w Katowicach | Not yet recruiting | Katowice | 40-032 | Poland |
| Uniwersytecki Szpital Kliniczny nr 1 Klinika Hematoonkologii i Transplantacji Szpiku | Not yet recruiting | Lublin | 20-081 | Poland |
| Uniwersytecki Szpital Kliniczny W Poznaniu | Not yet recruiting | Poznan | 60-569 | Poland |
| Instytut Hematologii i Transfuzjologii | Recruiting | Warsaw | 02-776 | Poland |
| ULS De Santo António, E.P.E. _H.Santo António_ Imunohemoterapia | Not yet recruiting | Porto | 4050-342 | Portugal |
| ULS São João, E.P.E._H.São João_Imunohemoterapia | Not yet recruiting | Porto | 4200-319 | Portugal |
| Hospital Vall d'Hebron | Recruiting | Barcelona | 08035 | Spain |
| Hospital Universitario La Paz | Recruiting | Madrid | 28046 | Spain |
| Hospital Regional Universitario de Málaga | Recruiting | Málaga | 29010 | Spain |
| Hospital Clinico Universitario de Salamanca | Recruiting | Salamanca | 37007 | Spain |
| Hospital La Fe - Hemostasia y Trombosis | Not yet recruiting | Valencia | 46026 | Spain |
| Skåne US - Koagulationsmottagning | Not yet recruiting | Malmö | 214 28 | Sweden |
| KS Solna - Koagulationsmottagningen | Not yet recruiting | Solna | 171 64 | Sweden |
| Zentrum für Labormedizin | Not yet recruiting | Sankt Gallen | 9008 | Switzerland |
| Queen Elizabeth Hospital, Birmingham - Haemophilia | Not yet recruiting | Birmingham | B15 2TH | United Kingdom |
| Royal Free Hospital - Haemophilia | Recruiting | London | NW3 2QG | United Kingdom |
| Royal Hallamshire Hospital | Not yet recruiting | Sheffield | S10 2JF | United Kingdom |
| ID | Term |
|---|---|
| D006467 | Hemophilia A |
| ID | Term |
|---|---|
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
Not provided
Not provided