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)

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04684914

Enrollment

Registered

2020-12-28

Start date

2020-12-26

Completion date

2024-04-17

Last updated

2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis B, Chronic

Keywords

Immunotherapy, CHB

Brief summary

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.

Interventions

BIOLOGICALHepTcell

Intramuscular injection

DRUGPlacebo

Intramuscular injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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).

Design outcomes

Primary

Measure	Time frame	Description
The Proportion of Patients Achieving Virologic Responses	Baseline to Day 169	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

Secondary

Measure	Time frame	Description
Changes in Quantitative HBsAg Level	Baseline to Days 85 and 169	—
Changes in HBV DNA Levels	Baseline to Days 85 and 169	—
Changes in Hepatitis B Core-related Antigen (HBCrAg) Levels	Baseline to Days 85 and 169	—
The Proportion of Patients Achieving Serologic Clearance of Hepatitis B Virus (HBV) DNA on Day 169	Baseline to Day 169	—
The Proportion of Patients Achieving Serologic Clearance of Hepatitis B Surface Antigen (HBsAg) on Day 169	Baseline to Day 169	—
Change in IFN-gamma Frequency by ELISpot Assay in PBMCs	Baseline to Days 85 and 169	Percent change in antigen-specific spot forming cells per million peripheral blood mononuclear cells (PBMCs)
Changes in Pre-genomic RNA Levels	Baseline to Days 85 and 169	—

Countries

Canada, Germany, Spain, United Kingdom, United States

Participant flow

Participants by arm

Arm	Count
HepTcell Dose administered at intervals of 4 weeks for 6 doses HepTcell: Intramuscular injection	41
Placebo Dose administered at intervals of 4 weeks for 6 doses Placebo: Intramuscular injection	43
Total	84

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Discontinued before receiving study treatment	1	2
Overall Study	Withdrawal by Subject	1	0

Baseline characteristics

Characteristic	Placebo	Total	HepTcell
Age, Continuous	53.21 years STANDARD_DEVIATION 8.08	52.11 years STANDARD_DEVIATION 8.6	50.95 years STANDARD_DEVIATION 9.07
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	24 Participants	51 Participants	27 Participants
Race (NIH/OMB) Black or African American	6 Participants	8 Participants	2 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants	2 Participants	0 Participants
Race (NIH/OMB) White	11 Participants	23 Participants	12 Participants
Region of Enrollment Canada	8 participants	14 participants	6 participants
Region of Enrollment Germany	1 participants	1 participants	0 participants
Region of Enrollment Italy	3 participants	9 participants	6 participants
Region of Enrollment Spain	11 participants	20 participants	9 participants
Region of Enrollment Thailand	12 participants	25 participants	13 participants
Region of Enrollment United Kingdom	4 participants	5 participants	1 participants
Region of Enrollment United States	4 participants	10 participants	6 participants
Sex: Female, Male Female	19 Participants	32 Participants	13 Participants
Sex: Female, Male Male	24 Participants	52 Participants	28 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 41	0 / 43
other Total, other adverse events	19 / 41	29 / 43
serious Total, serious adverse events	0 / 41	0 / 43

Outcome results

Primary

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

Population: mITT population

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
HepTcell	The Proportion of Patients Achieving Virologic Responses	1 Participants
Placebo	The Proportion of Patients Achieving Virologic Responses	0 Participants

p-value: 0.3029Chi-squared

p-value: 0.4881Fisher Exact

Secondary

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)