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New shot aims to clear hepatitis b virus in Long-Term patients

NCT ID NCT07190742

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

More trials for these conditions

Other studies related to the condition(s) this trial covers.