Hepatitis B, ChronicPhase 2NCT04684914
HepTcell Immunotherapy in Patients With Inactive Chronic Hepatitis B (CHB)
A Phase 2 study testing HepTcell in people with Hepatitis B, Chronic, run by Altimmune, Inc. at 21 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatitis B, Chronic
- What is being tested?
- HepTcell
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 87 participants
- Where
- 21 sitesin 5 countries
- Study dates
- 26 Dec 2020to 17 Apr 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
21 sites in 5 countries.
21 sites in 5 countries
Spain6 sites
Hospital Clínic De Barcelona
Barcelona, 08028
Hospital Universitari Vall D'Hebron
Barcelona, 08035
Hospital Universitario La Paz
Madrid, 28046
Hospital Nuestra Señora De Valme
Seville, 41014
Consorcio Hospital General Universitario De Valencia
Valencia, 46014
Hospital Universitari I Politècnic La Fe
Valencia, 46026
United States5 sites
Paragon Rx Clinical
Garden Grove, California, 92840
Kansas City Research Institute
Kansas City, Missouri, 64131
Central Sooner Research
Oklahoma City, Oklahoma, 73071
Stanford University Department of Medicine
Redwood City, California, 94063
San Jose Gastroenterology Institute
San Jose, California, 95128
Canada5 sites
University of Calgary Liver Unit - Heritage Medical Research Clinic
Calgary, Alberta, T2N 4Z6
University of Alberta Hospital
Edmonton, Alberta, T6G 2G3
The Ottawa Hospital
Ottawa, Ontario, K1H 8L6
Toronto Centre for Liver Disease (TCLD), Toronto General Hospital, UHN
Toronto, Ontario, M5G 2C4
Toronto Liver Centre
Toronto, Ontario, M6H 3M1
United Kingdom3 sites
St. Georges University of London
London, SW17 0RE
St. Mary's Hospital
London, W2 1NY
Queens Medical Center
Nottingham, NG7 2UH
Germany2 sites
Goethe University Hospital
Frankfurt am Main, 60590
Univesritätsklinikum Hamburg-Eppendorf
Hamburg, 20246
About this study
Official title: 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.
- Conditions
- Hepatitis B, Chronic
- Being tested
- HepTcell, Placebo
- Keywords
- Immunotherapy, CHB
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HepTcellBiological
Intramuscular injection
PlaceboDrug
Intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| HepTcell | Experimental | Dose administered at intervals of 4 weeks for 6 doses Receives: Biological: HepTcell |
| Placebo | Placebo comparator | Dose administered at intervals of 4 weeks for 6 doses Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline to Day 169
Secondary outcomes (7)
The Proportion of Patients Achieving Serologic Clearance of Hepatitis B Surface Antigen (HBsAg) on Day 169
Measured: Baseline to Day 169
The Proportion of Patients Achieving Serologic Clearance of Hepatitis B Virus (HBV) DNA on Day 169
Measured: Baseline to Day 169
Changes in Quantitative HBsAg Level
Measured: Baseline to Days 85 and 169
Changes in HBV DNA Levels
Measured: Baseline to Days 85 and 169
Changes in Hepatitis B Core-related Antigen (HBCrAg) Levels
Measured: Baseline to Days 85 and 169
Changes in Pre-genomic RNA Levels
Measured: 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)
Measured: Baseline to Days 85 and 169
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2020
- Study start26 Dec 2020
- Primary completion27 Mar 2024
- Study completion17 Apr 2024
Why it stopped: Did not meet endpoints
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hepatitis B, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Altimmune, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04684914
- Sponsor's protocol ID
- ALT-301-202
- Status last verified
- Dec 2025
- First submitted
- 22 Dec 2020
- Last updated
- 8 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT04684914
- Acronym / sponsor ID
- ALT-301-202
- Conditions
- Hepatitis B, Chronic
- Keywords
- Immunotherapy, CHB
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Did not meet endpoints
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Altimmune, Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Dec 2020 (actual)
- Primary completion
- 27 Mar 2024 (actual)
- Study completion
- 17 Apr 2024 (actual)
- First posted
- 28 Dec 2020 (actual)
- Results
- Posted 8 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HepTcell | Experimental | Biological: HepTcellDose administered at intervals of 4 weeks for 6 doses |
| Placebo | Placebo comparator | Drug: PlaceboDose administered at intervals of 4 weeks for 6 doses |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HepTcellIntramuscular injection | Biological | HepTcell |
| PlaceboIntramuscular injection | Drug | Placebo |
Primary outcome
The Proportion of Patients Achieving Virologic Responses
Time frame: 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
7 secondary outcomes
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
Time frame: Baseline to Days 85 and 169
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Hepatitis B, Chronic
Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
Hepatitis B
Active, not recruitingPhase 2
Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
Hepatitis B
Enrolling by invitationPhase 1
A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.
Chronic Hepatitis B
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
21 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HepTcell in people with Hepatitis B, Chronic, run by Altimmune, Inc. at 21 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Spain, United States, Canada, United Kingdom, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Proportion of Patients Achieving Virologic Responses (time frame: Baseline to Day 169). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.