Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Authorised, recruiting
Participants planned
15
Countries
2
Sites
7
Chronic hepatitis D 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
- 22 Apr 2026 → ongoing
- Decision date (initial)
- 2026-01-19
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Chronic hepatitis D infection
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 | 7 | 6 |
| Germany | Authorised, recruitment pending | 8 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Kolding Sygehus
Infectious Diseases, Sygehusvej 24, 6000, Kolding
Hvidovre Hospital
Infectious Diseases, Kettegaard Alle 36, 2650, Hvidovre
Rigshospitalet
Infectious Diseases, Blegdamsvej 9, 2100, Copenhagen Oe
Odense University Hospital
Infectious Diseases, Kloevervaenget 47, 5000, Odense C
Region Midtjylland
Infectious Diseases, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N
Aalborg University Hospital
Infectious Diseases, Moelleparkvej 4, 9000, Aalborg
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 | 2026-04-22 | 2026-04-23 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-09-11 | Denmark | Acceptable 2026-01-19
|
2026-01-19 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-04-24 | Denmark | Acceptable 2026-01-19
|
2026-04-24 |