Clinical trial • Phase I • Infectious Disease
synthetic long peptides (ISA104) for Chronic hepatitis B
Phase I trial of synthetic long peptides (ISA104) for Chronic hepatitis B. 24 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
- 06-11-2024
- First CTIS Authorization Date
- 27-11-2024
Trial design
Phase I trial across 1 site in Netherlands.
- Target Sample Size
- 24
Eligibility
Recruits 24 Vulnerable population not selected; no special consent or assent procedures are described in the record..
- Vulnerable Population
- Vulnerable population not selected; no special consent or assent procedures are described in the record.
Recruitment
- Planned Sample Size
- 24
- Recruitment Window Months
- 33
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 24
Netherlands
- Earliest CTIS Part Ii Submission Date
- 25-11-2024
- Latest Decision Or Authorization Date
- 22-09-2025
- Processing Time Days
- 301
- Number Of Sites
- 1
- Number Of Participants
- 24
Sites
- Site Name
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Department Name
- Gastroenterology and hepatology
- Contact Person Name
- Dave Sprengers
- Contact Person Email
- d.sprengers@erasmusmc.nl
- Number Of Participants
- 24
Sponsor
Primary sponsor
- Full Name
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Netherlands
Investigational products
- Investigational Product Name
- ISA104 (HEB-PEP)
- Active Substance
- synthetic long peptides (ISA104)
- Modality
- Vaccine|Peptide/protein/enzyme
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