Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruitment ended
Participants planned
30
Countries
1
Sites
2
Chronic Hepatitis B
Key facts
- Sponsor
- University Medical Center Hamburg-Eppendorf
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Virus Diseases [C02]
- Trial duration
- 8 Jul 2025 → ongoing
- Decision date (initial)
- 2024-10-28
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-514231-26-00
- EudraCT number
- 2022-000635-23
- ClinicalTrials.gov
- NCT05727267
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Chronic Hepatitis B
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | PT | 10008910 | Chronic hepatitis B | 100000004862 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
University Medical Center Hamburg-Eppendorf
- Sponsor organisation
- University Medical Center Hamburg-Eppendorf
- Address
- Martinistrasse 52, Eppendorf Eppendorf
- City
- Hamburg
- Postcode
- 20246
- Country
- Germany
Scientific contact point
- Organisation
- University Medical Center Hamburg-Eppendorf
- Contact name
- Svenja Hardtke
Public contact point
- Organisation
- University Medical Center Hamburg-Eppendorf
- Contact name
- Svenja Hardtke
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ongoing, recruitment ended | 30 | 2 |
| 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 | 2024-01-17 | 2024-01-25 | 2025-10-16 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 2 · Art. 38 CTR
Temporary halt TH-58482
- Halt date
- 2024-11-08
- Planned restart
- 2025-02-01
- Member states concerned
- Germany
- Publication date
- 2024-11-20
- Reason
- Sponsor decision
- Explanation
- Temporary halt for new recruitment only. Following the DSMB recommendation a substantial modification is planned for the last study arm.
All vaccinations scheduled to date, including for the other study arms, have already been completed and the subjects are in the follow-up period. - Follow-up measures
- substantial modification; all subjects will be monitored for safety until the end of the follow up period.
- Benefit-risk balance changed
- Yes
- Treatment stopped
- Yes
Temporary halt TH-78064
- Halt date
- 2025-04-04
- Planned restart
- 2025-06-01
- Member states concerned
- Germany
- Publication date
- 2025-04-07
- Reason
- Sponsor decision
- Explanation
- The recruitment of arm C0.3 was terminated by the sponsor, although the stipulated stopping criteria have not yet been reached. The sponsor's decision to discontinue the vaccination programme was precipitated by a reassessment of the risk-benefit ratio.
- Follow-up measures
- substantial modification; all subjects will be monitored for safety until the end of the follow up period.
- Benefit-risk balance changed
- Yes
- Treatment stopped
- Yes
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-07 | Germany | Acceptable 2024-10-24
|
2024-10-28 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-01-27 | Germany | Acceptable 2025-03-10
|
2025-03-17 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-05-20 | Germany | Acceptable 2025-06-30
|
2025-07-04 |