Trial Outcomes & Findings for HepTcell Immunotherapy in Patients With Inactive Chronic Hepatitis B (CHB) (NCT NCT04684914)
NCT ID: NCT04684914
Last Updated: 2025-12-08
Results Overview
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
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
87 participants
Primary outcome timeframe
Baseline to Day 169
Results posted on
2025-12-08
Participant Flow
Participant milestones
| Measure |
HepTcell
Dose administered at intervals of 4 weeks for 6 doses
HepTcell: Intramuscular injection
|
Placebo
Dose administered at intervals of 4 weeks for 6 doses
Placebo: Intramuscular injection
|
|---|---|---|
|
Overall Study
STARTED
|
42
|
45
|
|
Overall Study
Treated
|
41
|
43
|
|
Overall Study
COMPLETED
|
40
|
43
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
HepTcell
Dose administered at intervals of 4 weeks for 6 doses
HepTcell: Intramuscular injection
|
Placebo
Dose administered at intervals of 4 weeks for 6 doses
Placebo: Intramuscular injection
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Discontinued before receiving study treatment
|
1
|
2
|
Baseline Characteristics
HepTcell Immunotherapy in Patients With Inactive Chronic Hepatitis B (CHB)
Baseline characteristics by cohort
| Measure |
HepTcell
n=41 Participants
Dose administered at intervals of 4 weeks for 6 doses
HepTcell: Intramuscular injection
|
Placebo
n=43 Participants
Dose administered at intervals of 4 weeks for 6 doses
Placebo: Intramuscular injection
|
Total
n=84 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.95 years
STANDARD_DEVIATION 9.07 • n=37 Participants
|
53.21 years
STANDARD_DEVIATION 8.08 • n=37 Participants
|
52.11 years
STANDARD_DEVIATION 8.60 • n=74 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=37 Participants
|
19 Participants
n=37 Participants
|
32 Participants
n=74 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=37 Participants
|
24 Participants
n=37 Participants
|
52 Participants
n=74 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=74 Participants
|
|
Race (NIH/OMB)
Asian
|
27 Participants
n=37 Participants
|
24 Participants
n=37 Participants
|
51 Participants
n=74 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=74 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=37 Participants
|
6 Participants
n=37 Participants
|
8 Participants
n=74 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=37 Participants
|
11 Participants
n=37 Participants
|
23 Participants
n=74 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=74 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=37 Participants
|
2 Participants
n=37 Participants
|
2 Participants
n=74 Participants
|
|
Region of Enrollment
Canada
|
6 participants
n=37 Participants
|
8 participants
n=37 Participants
|
14 participants
n=74 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=37 Participants
|
4 participants
n=37 Participants
|
10 participants
n=74 Participants
|
|
Region of Enrollment
United Kingdom
|
1 participants
n=37 Participants
|
4 participants
n=37 Participants
|
5 participants
n=74 Participants
|
|
Region of Enrollment
Germany
|
0 participants
n=37 Participants
|
1 participants
n=37 Participants
|
1 participants
n=74 Participants
|
|
Region of Enrollment
Spain
|
9 participants
n=37 Participants
|
11 participants
n=37 Participants
|
20 participants
n=74 Participants
|
|
Region of Enrollment
Thailand
|
13 participants
n=37 Participants
|
12 participants
n=37 Participants
|
25 participants
n=74 Participants
|
|
Region of Enrollment
Italy
|
6 participants
n=37 Participants
|
3 participants
n=37 Participants
|
9 participants
n=74 Participants
|
PRIMARY outcome
Timeframe: Baseline to Day 169Population: mITT population
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
Outcome measures
| Measure |
HepTcell
n=41 Participants
Dose administered at intervals of 4 weeks for 6 doses
HepTcell: Intramuscular injection
|
Placebo
n=43 Participants
Dose administered at intervals of 4 weeks for 6 doses
Placebo: Intramuscular injection
|
|---|---|---|
|
The Proportion of Patients Achieving Virologic Responses
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline to Day 169Population: mITT
Outcome measures
| Measure |
HepTcell
n=41 Participants
Dose administered at intervals of 4 weeks for 6 doses
HepTcell: Intramuscular injection
|
Placebo
n=43 Participants
Dose administered at intervals of 4 weeks for 6 doses
Placebo: Intramuscular injection
|
|---|---|---|
|
The Proportion of Patients Achieving Serologic Clearance of Hepatitis B Surface Antigen (HBsAg) on Day 169
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline to Day 169Population: mITT
Outcome measures
| Measure |
HepTcell
n=41 Participants
Dose administered at intervals of 4 weeks for 6 doses
HepTcell: Intramuscular injection
|
Placebo
n=43 Participants
Dose administered at intervals of 4 weeks for 6 doses
Placebo: Intramuscular injection
|
|---|---|---|
|
The Proportion of Patients Achieving Serologic Clearance of Hepatitis B Virus (HBV) DNA on Day 169
|
5 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Baseline to Days 85 and 169Population: mITT. Number analyzed are the number of participants with data at each time point. Changes from baseline are calculated only for participants with non-missing values for both the baseline and time point of interest.
Outcome measures
| Measure |
HepTcell
n=41 Participants
Dose administered at intervals of 4 weeks for 6 doses
HepTcell: Intramuscular injection
|
Placebo
n=43 Participants
Dose administered at intervals of 4 weeks for 6 doses
Placebo: Intramuscular injection
|
|---|---|---|
|
Changes in Quantitative HBsAg Level
Day 85
|
-7.76 IU/mL
Standard Deviation 28.01
|
-8.47 IU/mL
Standard Deviation 15.85
|
|
Changes in Quantitative HBsAg Level
Day 169
|
-13.72 IU/mL
Standard Deviation 32.80
|
-10.19 IU/mL
Standard Deviation 31.87
|
SECONDARY outcome
Timeframe: Baseline to Days 85 and 169Population: mITT. Number analyzed are the number of participants with data at each time point. Changes from baseline are calculated only for participants with non-missing values for both the baseline and time point of interest.
Outcome measures
| Measure |
HepTcell
n=41 Participants
Dose administered at intervals of 4 weeks for 6 doses
HepTcell: Intramuscular injection
|
Placebo
n=43 Participants
Dose administered at intervals of 4 weeks for 6 doses
Placebo: Intramuscular injection
|
|---|---|---|
|
Changes in HBV DNA Levels
Day 85
|
-7559.73 IU/mL
Standard Deviation 46650.54
|
-5270.05 IU/mL
Standard Deviation 33240.79
|
|
Changes in HBV DNA Levels
Day 169
|
-7868.48 IU/mL
Standard Deviation 44871.40
|
-4690.12 IU/mL
Standard Deviation 32070.75
|
SECONDARY outcome
Timeframe: Baseline to Days 85 and 169Population: mITT. Number analyzed are the number of participants with data at each time point. Changes from baseline are calculated only for participants with non-missing values for both the baseline and time point of interest.
Outcome measures
| Measure |
HepTcell
n=41 Participants
Dose administered at intervals of 4 weeks for 6 doses
HepTcell: Intramuscular injection
|
Placebo
n=43 Participants
Dose administered at intervals of 4 weeks for 6 doses
Placebo: Intramuscular injection
|
|---|---|---|
|
Changes in Hepatitis B Core-related Antigen (HBCrAg) Levels
Day 85
|
-4.00 kU/mL
Standard Deviation 7.81
|
1.00 kU/mL
Standard Deviation NA
Data from a single subject
|
|
Changes in Hepatitis B Core-related Antigen (HBCrAg) Levels
Day 169
|
-1.00 kU/mL
Standard Deviation 1.00
|
1.00 kU/mL
Standard Deviation NA
Data from a single subject
|
SECONDARY outcome
Timeframe: Baseline to Days 85 and 169Population: mITT. Number analyzed are the number of participants with data at each time point. Changes from baseline are calculated only for participants with non-missing values for both the baseline and time point of interest.
Outcome measures
| Measure |
HepTcell
n=41 Participants
Dose administered at intervals of 4 weeks for 6 doses
HepTcell: Intramuscular injection
|
Placebo
n=43 Participants
Dose administered at intervals of 4 weeks for 6 doses
Placebo: Intramuscular injection
|
|---|---|---|
|
Changes in Pre-genomic RNA Levels
Day 85
|
0.26 Log U/mL
Standard Deviation 0.42
|
0.16 Log U/mL
Standard Deviation 0.39
|
|
Changes in Pre-genomic RNA Levels
Day 169
|
0.31 Log U/mL
Standard Deviation 0.44
|
0.30 Log U/mL
Standard Deviation 0.48
|
SECONDARY outcome
Timeframe: Baseline to Days 85 and 169Population: mITT. Number analyzed are the number of participants with data at each time point. Changes from baseline are calculated only for participants with non-missing values for both the baseline and time point of interest.
Percent change in antigen-specific spot forming cells per million peripheral blood mononuclear cells (PBMCs)
Outcome measures
| Measure |
HepTcell
n=41 Participants
Dose administered at intervals of 4 weeks for 6 doses
HepTcell: Intramuscular injection
|
Placebo
n=43 Participants
Dose administered at intervals of 4 weeks for 6 doses
Placebo: Intramuscular injection
|
|---|---|---|
|
Change in IFN-gamma Frequency by ELISpot Assay in PBMCs
Day 85
|
3.71 percent change
Standard Deviation 39.02
|
-0.14 percent change
Standard Deviation 21.50
|
|
Change in IFN-gamma Frequency by ELISpot Assay in PBMCs
Day 169
|
-5.28 percent change
Standard Deviation 28.56
|
3.45 percent change
Standard Deviation 45.56
|
Adverse Events
HepTcell
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
HepTcell
n=41 participants at risk
Dose administered at intervals of 4 weeks for 6 doses
HepTcell: Intramuscular injection
|
Placebo
n=43 participants at risk
Dose administered at intervals of 4 weeks for 6 doses
Placebo: Intramuscular injection
|
|---|---|---|
|
Infections and infestations
COVID-19
|
14.6%
6/41 • 6 months
|
9.3%
4/43 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.3%
3/41 • 6 months
|
7.0%
3/43 • 6 months
|
|
Nervous system disorders
Headache
|
4.9%
2/41 • 6 months
|
4.7%
2/43 • 6 months
|
|
General disorders
Pyrexia
|
4.9%
2/41 • 6 months
|
4.7%
2/43 • 6 months
|
|
Investigations
Neutrophil count decreased
|
2.4%
1/41 • 6 months
|
7.0%
3/43 • 6 months
|
|
Gastrointestinal disorders
Diarrhea
|
2.4%
1/41 • 6 months
|
4.7%
2/43 • 6 months
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/41 • 6 months
|
4.7%
2/43 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.4%
1/41 • 6 months
|
4.7%
2/43 • 6 months
|
|
Investigations
Influenza A virus test positive
|
0.00%
0/41 • 6 months
|
4.7%
2/43 • 6 months
|
|
General disorders
Fatigue
|
0.00%
0/41 • 6 months
|
4.7%
2/43 • 6 months
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/41 • 6 months
|
4.7%
2/43 • 6 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
2.4%
1/41 • 6 months
|
2.3%
1/43 • 6 months
|
|
Metabolism and nutrition disorders
Iron deficiency
|
2.4%
1/41 • 6 months
|
2.3%
1/43 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.4%
1/41 • 6 months
|
2.3%
1/43 • 6 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.4%
1/41 • 6 months
|
2.3%
1/43 • 6 months
|
|
Vascular disorders
Hypertension
|
2.4%
1/41 • 6 months
|
2.3%
1/43 • 6 months
|
|
Reproductive system and breast disorders
Breast pain
|
2.4%
1/41 • 6 months
|
2.3%
1/43 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place