A study to evaluate the antiviral effects, immunogenicity, and safety of HepTcell in treatment-naive patients with inactive chronic hepatitis B (CHB) and low hepatitis B surface antigen (HBsAg) levels.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
87
Paragon Rx Clinical
Garden Grove, California, United States
The Proportion of Patients Achieving Virologic Responses
Virologic response is defined as a 1.0-log reduction in quantitative hepatitis B surface antigen (HBsAg) or serologic clearance of HBsAg from Baseline to Day 169
Time frame: Baseline to Day 169
The Proportion of Patients Achieving Serologic Clearance of Hepatitis B Surface Antigen (HBsAg) on Day 169
Time frame: Baseline to Day 169
The Proportion of Patients Achieving Serologic Clearance of Hepatitis B Virus (HBV) DNA on Day 169
Time frame: Baseline to Day 169
Changes in Quantitative HBsAg Level
Time frame: Baseline to Days 85 and 169
Changes in HBV DNA Levels
Time frame: Baseline to Days 85 and 169
Changes in Hepatitis B Core-related Antigen (HBCrAg) Levels
Time frame: Baseline to Days 85 and 169
Changes in Pre-genomic RNA Levels
Time frame: Baseline to Days 85 and 169
Change in IFN-gamma Frequency by ELISpot Assay in PBMCs
Percent change in antigen-specific spot forming cells per million peripheral blood mononuclear cells (PBMCs)
Time frame: Baseline to Days 85 and 169
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