Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
48
Countries
2
Sites
7
Chronic hepatitis B infection
Key facts
- Sponsor
- Region Midtjylland
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Virus Diseases [C02]
- Trial duration
- 26 Aug 2024 → ongoing
- Decision date (initial)
- 2024-06-28
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Chronic hepatitis B infection
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | PT | 10008910 | Chronic hepatitis B | 100000004862 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Region Midtjylland
- Sponsor organisation
- Region Midtjylland
- Address
- Palle Juul-Jensens Boulevard 99
- City
- Aarhus N
- Postcode
- 8200
- Country
- Denmark
Scientific contact point
- Organisation
- Region Midtjylland
- Contact name
- Department of Infectious Diseases
Public contact point
- Organisation
- Region Midtjylland
- Contact name
- Department of Infectious Diseases
Locations
2 EU/EEA countries · 7 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruiting | 24 | 6 |
| Germany | Ongoing, recruiting | 24 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Kolding Sygehus
Dept. of Infectious Diseases, Sygehusvej 24, 6000, Kolding
Odense University Hospital
Dept. of Infectious Diseases, Kloevervaenget 47, 5000, Odense C
Hvidovre Hospital
Dept. of Infectious Diseases, Kettegaard Alle 36, 2650, Hvidovre
Rigshospitalet
Dept. of Infectious Diseases, Blegdamsvej 9, 2100 Cph, København
Aalborg University Hospital
Dept. of Infectious Diseases, Moelleparkvej 4, 9000, Aalborg
Region Midtjylland
Dept. of Infectious Diseases, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N
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 |
|---|---|---|---|---|---|
| Denmark | 2024-08-26 | 2024-08-26 | |||
| Germany | 2024-09-16 | 2024-09-16 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-04-18 | Denmark | Acceptable 2024-06-28
|
2024-06-28 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-07-01 | Denmark | Acceptable 2024-06-28
|
2024-07-01 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2024-09-05 | Denmark | Acceptable 2024-06-28
|
2024-09-05 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2024-09-16 | Acceptable 2024-06-28
|
2024-09-16 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-01-21 | Denmark | Acceptable 2025-03-21
|
2025-03-26 |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-07-02 | Denmark | Acceptable 2025-08-31
|
2025-09-01 |