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Not yet recruitingNCT07897448Updated Oct 27, 2026

A Study of Sequential Therapy With AHB-137 Injection Followed by TVAX-008 Injection in Participants Living With Chronic Hepatitis B (CHB)

A Phase 1/2 interventional study of AHB-137 and TVAX-008 in Chronic Hepatitis B, sponsored by Grand Theravac Life Sciences (Hangzhou) Co., Ltd.. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-27.

Sponsored by Grand Theravac Life Sciences (Hangzhou) Co., Ltd. · Phase 1/2, Interventional, and Treatment

Updated Oct 27, 2026Newly registeredGo to Updates ↓
Phase
Phase 1/2
Study type
Interventional
Enrollment
105
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

This is a study of sequential therapy with AHB-137 injection followed by TVAX-008 injection in participants living with Chronic Hepatitis B (CHB).

02

Conditions studied

  • Chronic Hepatitis B

Keywords

  • Hepatitis B
  • Chronic
03

In context

Hepatitis B, Chronic

895 studies on the registry are indexed under Hepatitis B, Chronic; 151 are open to participants now.

This study's planned enrollment of 105 is close to the median of 100 across 659 interventional studies indexed under Hepatitis B, Chronic.

Browse Hepatitis B, Chronic studies →

Lead sponsor

This is the only study on the registry with Grand Theravac Life Sciences (Hangzhou) Co., Ltd. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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.

Inclusion criteria

  • Voluntarily participate in the study and sign the form, and comply with the requirements of the study protocol;
  • 18-65 years of age (including boundary values) for men or women;
  • met the requirements;
  • HBeAg negative at screening;
  • Meet the relevant requirements for prior medications;
  • and HBV DNA and liver function indicators meet the requirements;
  • Use as required;

Exclusion criteria

Exclusion Criteria:

  • Uncontrolled and stable abnormalities or other serious diseases other than a history of chronic infection;
  • Has received treatment with the relevant medication;
  • Participants with clinically significant relevant liver diseases, manifestations of liver function decompensation, history of extrahepatic diseases related to HBV immune status, liver fibrosis or cirrhosis, and confirmed or suspected liver cancer;
  • Any serious infection other than chronic hepatitis B infection requires intravenous anti-infective therapy;
  • positive, antibody positive, syphilis positive within 12 months;
  • Abnormal laboratory results;
  • Diseases associated with vascular inflammatory conditions;
  • corrected heart rate (Fridericia method) abnormal;
  • History of or ongoing assessment of possible malignancy;
  • History of allergies, or allergic constitution;
  • Recent major trauma or major surgery, or planned surgery;
  • Those who are participating in another clinical trial, or have not undergone a protocol-specified prior to this study;
  • Prior/current use of prohibited medications;
  • Thyroid function abnormal;
  • There are serious cardiovascular and cerebrovascular diseases;
  • Inappropriate for participation in this trial as judged by the investigator
Terms in these criteria, in plain language(10)

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.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

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.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Washout period

A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
105 participants (estimated)

Study arms

  • Experimental
    Experiment group

    Drug: AHB-137 · Drug: TVAX-008

  • Placebo comparator
    Placebo group

    Drug: AHB-137 · Drug: Placebo

Interventions

  • AHB-137 will be administered per 1 week

  • TVAV-008 will be administered per 4 weeks

  • AHB-137 will be administered per 1 week

  • DrugPlacebo

    Placebo will be used per 4 weeks

06

What researchers measure

Primary outcomes

  1. Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) in Phase I

    Treatment-emergent adverse events (TEAEs) will be assessed during the protocol-defined observation period. The percentage of participants experiencing at least one TEAE will be reported.

    Time frame: From the first dose of study treatment through the last study visit (up to Week 72)

  2. Percentage of Participants Achieving Clinical Cure (Functional Cure) at 24 Weeks After Discontinuation of All Chronic Hepatitis B Treatments in Phase II

    Clinical cure is defined as HBsAg clearance (\<0.05 IU/mL) and sustained HBV DNA suppression (\<LLOQ), allowing transient viral rebound, at 24 weeks after discontinuation of all CHB treatments, regardless of HBsAb status. The percentage of participants achieving clinical cure will be reported.

    Time frame: 24 weeks after discontinuation of all chronic hepatitis B treatments (up to Week 72)

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 27, 2026
Show all 1 update
  1. Oct 27, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07897448
Lead sponsor
Grand Theravac Life Sciences (Hangzhou) Co., Ltd.
Responsible party
Sponsor
First posted
Oct 27, 2026
Start date
Oct 31, 2026 (estimated)
Primary completion
Sep 22, 2028 (estimated)
Completion
Jun 20, 2029 (estimated)
Last update
Oct 27, 2026

Study contacts

Lina Chen
Contact
chenlina@theravac.cn
086+19921306230
Guiqiang Wang
principal investigator · Peking University First Hospital
Yan Wang
principal investigator · Peking University First Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Studies of the drug tested here: TVAX-008

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