Clinical trial • Phase I • Infectious Disease
Clinical trial in Chronic hepatitis B
Phase I trial for Chronic hepatitis B. None/Not specified-controlled, adaptive. 30 participants.
Overview
- Trial Therapeutic Area
- Infectious Disease
- Trial Disease
- Chronic hepatitis B
- Trial Stage
- Phase I
- Drug Modality
- Vaccine|Peptide/protein/enzyme
Key dates
- Initial CTIS Submission Date
- 07-10-2024
- First CTIS Authorization Date
- 28-10-2024
Trial design
None/Not specified-controlled, adaptive Phase I trial across 2 sites in Germany.
- Comparator
- None/Not specified
- Adaptive
- True, Dose-escalation elements described (planned dose escalation of one vaccine component; stopping criteria and DSMB oversight referenced; sponsor decisions led to halting or modification of escalation).
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 30
Eligibility
Recruits 30 isVulnerablePopulationSelected = true in the CTIS record; no further consent or assent handling details provided in the available documents..
- Vulnerable Population
- isVulnerablePopulationSelected = true in the CTIS record; no further consent or assent handling details provided in the available documents.
Recruitment
- Planned Sample Size
- 30
- Recruitment Window Months
- 26
Geography
- Total Number Of Sites
- 2
- Total Number Of Participants
- 30
Germany
- Earliest CTIS Part Ii Submission Date
- 18-10-2024
- Latest Decision Or Authorization Date
- 04-07-2025
- Processing Time Days
- 259
- Number Of Sites
- 2
- Number Of Participants
- 30
Sites
- Site Name
- Bernhard-Nocht-Institut Fuer Tropenmedizin
- Department Name
- Bernhardt Nocht Clinical Trial Center
- Contact Person Name
- Marylyn Addo
- Contact Person Email
- m.addo@uke.de
- Site Name
- Klinikum der Universitaet Muenchen AöR
- Department Name
- Division of Infectious Disease and Tropical medicine
- Contact Person Name
- Mirjam Schunk
- Contact Person Email
- Mirjam.Schunk@med.uni-muenchen.de
Sponsor
Primary sponsor
- Full Name
- University Medical Center Hamburg-Eppendorf
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Germany
Investigational products
- Combination Treatment
- Yes
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