New shot aims to clear hepatitis b virus in Long-Term patients
NCT ID NCT07190742
First seen Jun 24, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This Phase 2 trial tests an injection called TVAX-008 in 80 adults with chronic hepatitis B who are already on antiviral pills. Half get TVAX-008 plus their usual medication, half get a placebo plus their usual medication, for 24 weeks. The goal is to see if TVAX-008 can make the hepatitis B surface antigen disappear, which would mean better control of the infection.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- TVAX-008 injection
- What this could lead to
- If successful, TVAX-008 could help some people with chronic hepatitis B clear the virus surface antigen, potentially leading to better disease control.
- What could go wrong
- This is a small, early Phase 2 trial with only 80 participants. The treatment may not work better than placebo, and long-term safety is not yet known.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jun 2023
- Expected to finish
-
May 2026
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 65 years
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Voluntary signing of the informed consent form, understanding of the study and willingness to follow and ability to complete all trial procedures; 2. Male or female, age 18-65 (including thresholds) 3. Clinically diagnosed chronic hepatitis B (HBsAg positive serum ≥6 months) 4. Subjects receiving antiviral therapy with a single nucleotide analogue such as tenofovir fumarate (TAF), tenofovir amitidine (TMF), tenofovir disotil fumarate (TDF), or entecavir (ETV) and HBV DNA\<100 IU/mL within 28 days prior to first dose of investigational product 5. HBeAg negative within 28 days prior to first use of investigational product 6. HBsAg\>0.05 IU/mL and HBsAg\<100 IU/mL within 28 days prior to first use of investigational product Exclusion Criteria: 1. Clinically important chronic diseases other than chronic hepatitis B that, in the opinion of the investigator, make the patient unsuitable for participation in the study 2. Laboratory indicators or symptoms meet one or more of the following: 1) blood phosphorus \<0.65 mmol/L; 2) serum albumin \<35 g/L; 3) total bilirubin\> 1.5 × ULN; 4) hemoglobin \<90 g/L; 5) international normalized ratio of prothrombin time ≥ 1.5; 6) ascites, varicose vein bleeding, hepatorenal syndrome, hepatic encephalopathy or liver failure; 7) platelet count \<90 × 109/L; INR 8) absolute neutrophil count \<1.2 × 109/L; 9) serum creatinine\> 1.5 × ULN or creatinine clearance \<50 mL/min/1.73m2; imaging findings showing cirrhosis or liver space-occupying lesions (except liver cysts or hemangiomas) 3. Treatment with interferon or pegylated interferon within 12 weeks prior to first use of investigational product or planned treatment with interferon or pegylated interferon during the trial 4. Use of immunosuppressants within 6 months prior to first use of investigational product 5. Treatment with corticosteroids (other than topical or inhaled corticosteroids) for 1 week or more within 6 months prior to first use of investigational product
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Peking University first hospital
Beijing, 10000, China
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Other studies related to the condition(s) this trial covers.
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