Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
108
Countries
1
Sites
1
Prophylaxis and on-demand treatment respectively in patients with haemophilia A with or without FVIII inhibitors.
Key facts
- Sponsor
- Novo Nordisk A/S
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
- Trial duration
- 16 Sep 2024 → 26 Mar 2026
- Decision date (initial)
- 2024-09-16
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-506520-90-00
- WHO UTN
- U1111-1292-7153
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Prophylaxis and on-demand treatment respectively in patients with haemophilia A with or without FVIII inhibitors.
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
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 108 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
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 |
|---|---|---|---|---|---|
| Germany | 2024-09-16 | 2026-03-26 | 2024-09-23 | 2026-02-17 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-05 | Germany | Acceptable 2024-09-09
|
2024-09-16 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-09-27 | Germany | Acceptable 2024-09-09
|
2024-09-27 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-08-27 | Germany | Acceptable with conditions 2025-10-09
|
2025-10-09 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-10-20 | Germany | Acceptable 2025-11-18
|
2025-11-18 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-12-11 | Germany | Acceptable 2025-11-18
|
2025-12-11 |