Clinical trial • Phase I • Infectious Disease
Clinical trial in Chronic hepatitis B | Chronic hepatitis B infection
Phase I trial for Chronic hepatitis B | Chronic hepatitis B infection. 48 participants.
Overview
- Trial Therapeutic Area
- Infectious Disease
- Trial Disease
- Chronic hepatitis B | Chronic hepatitis B infection
- Trial Stage
- Phase I
- Drug Modality
- Other antibody
Key dates
- Initial CTIS Submission Date
- 18-04-2024
- First CTIS Authorization Date
- 28-06-2024
Trial design
Phase I trial across 7 sites in Denmark, Germany.
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 48
Eligibility
Recruits 48 Vulnerable population(s) selected in the trial record; no details on specific vulnerable groups, consent, or assent handling are provided in the available documents..
- Vulnerable Population
- Vulnerable population(s) selected in the trial record; no details on specific vulnerable groups, consent, or assent handling are provided in the available documents.
Recruitment
- Planned Sample Size
- 48
- Recruitment Window Months
- 36
Geography
- Total Number Of Sites
- 7
- Total Number Of Participants
- 48
Denmark
- Earliest CTIS Part Ii Submission Date
- 12-04-2024
- Latest Decision Or Authorization Date
- 01-09-2025
- Processing Time Days
- 507
- Number Of Sites
- 6
- Number Of Participants
- 24
Sites
- Site Name
- Odense University Hospital
- Department Name
- Dept. of Infectious Diseases
- Contact Person Name
- Isik Somuncu Johansen
- Contact Person Email
- isik.somuncu.johansen@rsyd.dk
- Site Name
- Kolding Sygehus
- Department Name
- Dept. of Infectious Diseases
- Contact Person Name
- Lone Wulff Madsen
- Contact Person Email
- Lone.Wulff.Madsen@rsyd.dk
- Site Name
- Aalborg University Hospital
- Department Name
- Dept. of Infectious Diseases
- Contact Person Name
- Karina Kirk
- Contact Person Email
- kfk@rn.dk
- Site Name
- Hvidovre Hospital
- Department Name
- Dept. of Infectious Diseases
- Contact Person Name
- Nina Weis
- Contact Person Email
- nina.weis@regionh.dk
- Site Name
- Region Midtjylland
- Department Name
- Dept. of Infectious Diseases
- Contact Person Name
- Ole Schmeltz Søgaard
- Contact Person Email
- olesoega@rm.dk
- Site Name
- Rigshospitalet
- Department Name
- Dept. of Infectious Diseases
- Contact Person Name
- Jan Gerstoft
- Contact Person Email
- jan.gerstoft@regionh.dk
Germany
- Earliest CTIS Part Ii Submission Date
- 10-06-2024
- Latest Decision Or Authorization Date
- 04-09-2025
- Processing Time Days
- 451
- Number Of Sites
- 1
- Number Of Participants
- 24
Sites
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- Department of Infectious Diseases and Critical Care Medicine
- Contact Person Name
- Christian Gaebler
- Contact Person Email
- infektiologie-pneumologie@charite.de
Sponsor
Primary sponsor
- Full Name
- Region Midtjylland
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Denmark
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