HepTcell Immunotherapy in Patients With Inactive Chronic Hepatitis B (CHB)

Phase 2, Double-blind, Randomized, Placebo-controlled Study of HepTcell (Adjuvanted FP-02.2) as an Immunotherapeutic Vaccine in Treatment-naïve Patients With Inactive Chronic Hepatitis B (CHB)

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.

Inclusion Criteria:

• Men and women 18 to 65 years of age, inclusive
• Inactive CHB with documented HBsAg positivity for at least 12 months before Day 1
• qHBsAg ≥ 10 IU/mL but ≤ 100 IU/mL in the 12 months prior to screening
• HBV DNA ≥ 10 IU/mL at screening
• AST, ALT, INR, albumin, total bilirubin (excluding patients with Gilbert Syndrome) and direct bilirubin within normal limits at screening

Exclusion Criteria:

• Positive hepatitis B e antigen (HBeAg) at screening
• History of a hepatitis B flare or 1-log increase in HBV DNA or HBsAg in the prior 12 months
• Undetectable HBV DNA at screening
• Fibroscan > 8.5 kPA at screening, or history of hepatic fibrosis or cirrhosis (NB, a Fibroscan is not required if an examination is performed within 12 months or a liver biopsy was performed within 2 years before Screening and no fibrosis [F1 or greater] was identified).