Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
35
Countries
7
Sites
22
Haemophilia A with or without inhibitors. Proposed indication under development: prevention of bleeding and long-term prophylaxis in patients with haemophilia A, irrespective of inhibitor status or severity.
Key facts
- Sponsor
- Novo Nordisk A/S
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
- Trial duration
- 13 Oct 2025 → ongoing
- Decision date (initial)
- 2025-09-22
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
External identifiers
- EU CT number
- 2025-520490-38-00
- WHO UTN
- U1111-1317-4366
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Haemophilia A with or without inhibitors. Proposed indication under development: prevention of bleeding and long-term prophylaxis in patients with haemophilia A, irrespective of inhibitor status or severity.
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Novo Nordisk A/S
- Sponsor organisation
- Novo Nordisk A/S
- Address
- Novo Alle 1
- City
- Bagsvaerd
- Postcode
- 2880
- Country
- Denmark
Scientific contact point
- Organisation
- Novo Nordisk A/S
- Contact name
- EU Submission Hub
Public contact point
- Organisation
- Novo Nordisk A/S
- Contact name
- EU Submission Hub
Locations
7 EU/EEA countries · 22 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruiting | 4 | 2 |
| Germany | Ongoing, recruiting | 6 | 3 |
| Italy | Ongoing, recruiting | 2 | 2 |
| Poland | Ongoing, recruiting | 4 | 6 |
| Portugal | Authorised, recruitment pending | 2 | 2 |
| Spain | Ongoing, recruiting | 5 | 5 |
| Sweden | Authorised, recruitment pending | 3 | 2 |
| Rest of world
United States, United Kingdom
|
— | 9 | — |
Investigational sites
Medizinische Universitaet Innsbruck
Univ.-Klinik für Innere Medizin V, Hämatologie und Onkologie, Anichstrasse 35, 6020, Innsbruck
Medical University Of Vienna
Univ.-Klinik für Innere Medizin I, Klinische Abteilung für Hämatologie und Hämostaseologie, Waehringer Guertel 18-20, Alsergrund, Vienna
Vivantes Netzwerk fuer Gesundheit GmbH
Vivantes Berlin-Friedrichshain, Innere Medizin VI, Landsberger Allee 49, Friedrichshain, Berlin
Medizinische Hochschule Hannover
Haematologie, Gerinnungsambulanz, Carl-Neuberg-Strasse 1, Gross Buchholz, Hanover
Universitaetsklinikum Bonn AöR
Institut für Experimentelle Hämatologie, Venusberg-Campus 1, Venusberg, Bonn
Azienda Ospedaliero Universitaria Careggi
N/A, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
Azienda Ospedaliera Universitaria Federico II Di Napoli
N/A, Via Sergio Pansini 5, 80131, Naples
Uniwersyteckie Centrum Kliniczne
Klinika Hematologi, Transplantologii i Terapii Komórkowych, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Uniwersytecki Szpital Kliniczny W Bialymstoku
Klinika Hematologii, Ch. Wewn. i Angiologii z Pododdziałem Transplantacji Komórek Krwiotwórczych, Ul. Marii Curie-Sklodowskiej 24a, 15-276, Bialystok
Instytut Hematologii I Transfuzjologii
Klinika Zaburzeń Hemostazy i Chorób Wewnętrznych, Ul Indiry Gandhi 14, 02-776, Warsaw
Samodzielny Publiczny Szpital Kliniczny Im.Andrzeja Mieleckiego Slaskiego Uniwersytetu Medycznego W Katowicach
Oddział Hematologii i Transplantacji Szpiku, Ul. Henryka Dabrowskiego 25, 40-032, Katowice
Uniwersytecki Szpital Kliniczny Nr 1 W Lublinie
Klinika Hematoonkologii i Transplantacji Szpiku, Ul. Stanislawa Staszica 11, 20-081, Lublin
Uniwersytecki Szpital Kliniczny W Poznaniu
Klinika Hematologii, Transplantacji i Terapii Komórkowej, Ul. Augustyna Szamarzewskiego 84, 60-569, Poznan
Unidade Local De Saude De Santo Antonio E.P.E.
N/A, Rua Dom Manuel II 57, 1508, Porto
Unidade Local de Saude de Sao Joao E.P.E.
N/A, Alameda Professor Hernani Monteiro, 4200-319, Porto
Hospital Universitario La Paz
N/A, Paseo De La Castellana 261, 28046, Madrid
Hospital Universitario De Salamanca
N/A, Paseo De San Vicente 58-182, 37007, Salamanca
Hospital Universitario Regional De Malaga
N/A, Avenida De Carlos De Haya S/N, 29010, Malaga
Hospital Universitario Y Politecnico La Fe
N/A, Avenida Fernando Abril Martorell 106, 46026, Valencia
Hospital Universitari Vall D Hebron
N/A, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Austria | 2025-10-21 | 2025-10-23 | |||
| Germany | 2025-10-13 | 2025-10-30 | |||
| Italy | 2025-10-27 | 2025-11-11 | |||
| Poland | 2025-10-24 | 2025-10-30 | |||
| Spain | 2025-10-17 | 2025-11-05 |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-05-30 | Germany | Acceptable 2025-09-22
|
2025-09-22 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-12-05 | Germany | Acceptable 2025-09-22
|
2025-12-05 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-12-12 | Germany | Acceptable 2026-02-09
|
2026-02-09 |
| 4 | SUBSEQUENT ADDITION OF MSC | APP-4 | 2026-04-17 | 2026-05-28 | ||
| 5 | SUBSEQUENT ADDITION OF MSC | APP-5 | 2026-04-17 | 2026-05-29 | ||
| 6 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-04-27 | Acceptable | 2026-06-02 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-04-27 | Germany | Acceptable | 2026-05-07 |
| 8 | SUBSTANTIAL MODIFICATION | SM-4 | 2026-04-27 | Acceptable | 2026-05-08 |