A Phase 2 interventional study of HepTcell and Placebo in Hepatitis B, Chronic, sponsored by Altimmune, Inc.. Terminated at 21 sites in 5 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-12-08.
Sponsored by Altimmune, Inc. · Phase 2, Interventional, and Treatment
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.
895 studies on the registry are indexed under Hepatitis B, Chronic; 151 are open to participants now.
This study's enrollment of 87 is below the median of 100 across 659 interventional studies indexed under Hepatitis B, Chronic.
Browse Hepatitis B, Chronic studies →Altimmune, Inc. is the lead sponsor of 20 studies on the registry; 1 is open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 4 (29%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Dose administered at intervals of 4 weeks for 6 doses
Biological: HepTcell
Dose administered at intervals of 4 weeks for 6 doses
Drug: Placebo
Intramuscular injection
Intramuscular injection
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
| Milestone | HepTcell | Placebo |
|---|---|---|
| Started | 42 | 45 |
| Treated | 41 | 43 |
| Completed | 40 | 43 |
| Not completed | 2 | 2 |
| Withdrew: Withdrawal by subject | 1 | 0 |
| Withdrew: Discontinued before receiving study treatment | 1 | 2 |
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
| Participants | HepTcell | Placebo |
|---|---|---|
| The Proportion of Patients Achieving Virologic Responses | 1 | 0 |
| Participants | HepTcell | Placebo |
|---|---|---|
| The Proportion of Patients Achieving Serologic Clearance of Hepatitis B Surface Antigen (HBsAg) on Day 169 | 1 | 0 |
| Participants | HepTcell | Placebo |
|---|---|---|
| The Proportion of Patients Achieving Serologic Clearance of Hepatitis B Virus (HBV) DNA on Day 169 | 5 | 8 |
| IU/mL | HepTcell | Placebo |
|---|---|---|
| Day 85 | -7.76 ± 28.01 | -8.47 ± 15.85 |
| Day 169 | -13.72 ± 32.80 | -10.19 ± 31.87 |
| IU/mL | HepTcell | Placebo |
|---|---|---|
| Day 85 | -7559.73 ± 46650.54 | -5270.05 ± 33240.79 |
| Day 169 | -7868.48 ± 44871.40 | -4690.12 ± 32070.75 |
| kU/mL | HepTcell | Placebo |
|---|---|---|
| Day 85 | -4.00 ± 7.81 | 1.00 ± NA |
| Day 169 | -1.00 ± 1.00 | 1.00 ± NA |
| Log U/mL | HepTcell | Placebo |
|---|---|---|
| Day 85 | 0.26 ± 0.42 | 0.16 ± 0.39 |
| Day 169 | 0.31 ± 0.44 | 0.30 ± 0.48 |
Percent change in antigen-specific spot forming cells per million peripheral blood mononuclear cells (PBMCs)
| percent change | HepTcell | Placebo |
|---|---|---|
| Day 85 | 3.71 ± 39.02 | -0.14 ± 21.50 |
| Day 169 | -5.28 ± 28.56 | 3.45 ± 45.56 |
Collected over 6 months. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| HepTcell | 0/41 (0%) | 0/41 (0%) | 19/41 (46.3%) |
| Placebo | 0/43 (0%) | 0/43 (0%) | 29/43 (67.4%) |
| Event | HepTcell | Placebo |
|---|---|---|
| COVID-19Infections and infestations | 6/41 | 4/43 |
| Back painMusculoskeletal and connective tissue disorders | 3/41 | 3/43 |
| Neutrophil count decreasedInvestigations | 1/41 | 3/43 |
| HeadacheNervous system disorders | 2/41 | 2/43 |
| PyrexiaGeneral disorders | 2/41 | 2/43 |
| DiarrheaGastrointestinal disorders | 1/41 | 2/43 |
| Food poisoningGastrointestinal disorders | 0/41 | 2/43 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 1/41 | 2/43 |
| Influenza A virus test positiveInvestigations | 0/41 | 2/43 |
| FatigueGeneral disorders | 0/41 | 2/43 |
mITT population: all randomized subjects who received any amount of study medication and had a baseline and at least one postbaseline efficacy assessment
| Age, Continuous(years) | HepTcell | Placebo | Total |
|---|---|---|---|
| Mean | 50.95 ± 9.07 | 53.21 ± 8.08 | 52.11 ± 8.60 |
| Sex: Female, Male(Participants) | HepTcell | Placebo | Total |
|---|---|---|---|
| Female | 13 | 19 | 32 |
| Male | 28 | 24 | 52 |
| Race (NIH/OMB)(Participants) | HepTcell | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 27 | 24 | 51 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 2 | 6 | 8 |
| White | 12 | 11 | 23 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 2 | 2 |
| Region of Enrollment(participants) | HepTcell | Placebo | Total |
|---|---|---|---|
| Canada | 6 | 8 | 14 |
| United States | 6 | 4 | 10 |
| United Kingdom | 1 | 4 | 5 |
| Germany | 0 | 1 | 1 |
| Spain | 9 | 11 | 20 |
| Thailand | 13 | 12 | 25 |
| Italy | 6 | 3 | 9 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Dec 2020 to primary completion in Mar 2024, 39 months.
Results were first posted in Dec 2025, 1 year 8 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Altimmune, Inc.