Ignite Creation Date:
2024-05-06 @ 6:57 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05841095
Status:
RECRUITING
Last Update Posted:
2024-02-20
First Post:
2023-03-27
Brief Title:
Evaluation of the Novel Therapeutic Hepatitis B Virus Synthetic Long Peptide Vaccination ISA104
Sponsor:
Erasmus Medical Center
Organization:
Erasmus Medical Center
Study Overview
Official Title:
Phase III Study to Determine the Safety Immunogenicity and Efficacy of the Therapeutic Hepatitis B Virus Synthetic Long Peptide Vaccination ISA104
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HEB-PEP
Brief Summary:
The goal of this clinical trial is to test ISA104 in patients with chronic hepatitis B The main questions it aims to answer are
How safe is ISA104
Does ISA104 induce immunity against hepatitis B virus
Different doses of the vaccine ISA104 will be administered to participants These participants are chronic HBV patients being actively treated with antiviral drugs
Researchers will compare the ISA104 vaccine to a placebo
How safe is ISA104
Does ISA104 induce immunity against hepatitis B virus
Different doses of the vaccine ISA104 will be administered to participants These participants are chronic HBV patients being actively treated with antiviral drugs
Researchers will compare the ISA104 vaccine to a placebo
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None