Chronic hepatitisBPhase 3NCT07282249
Clinical Trial to Evaluate the Efficacy and Safety of TVAX-008 Injection in the Treatment of Chronic Hepatitis B
A Phase 3 study testing TVAV-008, PegIFNα2b and Placeb in people with Chronic hepatitisB, run by Grand Theravac Life Sciences (Nanjing) Co., Ltd..
Trial summary
This is a multicenter, randomized, placebo-controlled (double-blind design) versus active-controlled (open-label design) Phase I clinical trial evaluating the efficacy and safety of TVAX-008 injection in subjects with chronic hepatitis B. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic hepatitisB
- What is being tested?
- TVAV-008, PegIFNα2b and Placeb
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 630 participants
- Where
- No sites listed yet
- Study dates
- 31 Dec 2025to 31 Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- Male or female, aged 18 to 65 years (inclusive);
- Clinically diagnosed chronic hepatitis B (serum HBsAg positive ≥6 months);
- Subjects with a history of nucleoside (acid) analog anti-hepatitis B therapy lasting ≥6 months until screening, currently receiving antiviral therapy with a single nucleoside (acid) analog [eg, tenofovir fumarate (TAF), amitenofovir (TMF), tenofovir disoform fumarate (TDF) or entecavir (ETV), etc.], and HBV DNA<100 IU/mL within 28 days prior to the first dose of investigational product;
- Hepatitis B virus e antigen (HBeAg) negative within 28 days prior to first use of investigational product;
- HBsAg>0.05 IU/mL and HBsAg<100 IU/mL within 28 days prior to first use of investigational product;
- Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2× upper limit of normal (ULN) within 28 days prior to the first dose of investigational product;
- Antinuclear antibodies (ANA) negative, or abnormal but not supportive of diagnosis of autoimmune liver disease in the investigator's judgment;
Who cannot join
- Liver disease caused by other causes, including alcoholic liver disease, nonalcoholic steatohepatitis, drug-induced hepatitis, hemochromatosis, etc.;
- In addition to chronic hepatitis B, clinically important chronic diseases that, in the opinion of the investigator, make the patient unsuitable for participation in the study, including but not limited to thyroid disease requiring clinical intervention or clinically significant thyroid dysfunction, fundus disease (e.g. retinopathy), chronic lung disease with lung dysfunction, history of severe seizures or current use of antiepileptic drugs, immunodeficiency or autoimmune disease;
- Laboratory indicators or symptoms meet one or more of the following:
- Blood phosphorus <0.65 mmol/L;
- Serum albumin <35 g/L;
- Total bilirubin>1.5×ULN;
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- Hemoglobin <100 g/L;
- Prothrombin time international normalized ratio (INR) ≥1.5;
- Past or present ascites, variceal bleeding, hepatorenal syndrome, hepatic encephalopathy or liver failure;Child-Pugh score B/C (see Appendix 1 for Child-Pugh classification criteria);
- Platelet count <125×109/L;
- WBC count <3×109/L;
- Absolute neutrophil count <1.5×109/L;
- Estimated glomerular filtration rate (eGFR)<50 mL/min/1.73m2[calculated using the Chronic Kidney Disease Epidemiology Collaboration formula (CKD-EPI formula), see Appendix 2 for CKD-EPI formula];
- Imaging results show hepatocellular carcinoma, cirrhosis or liver mass (except liver cyst or hemangioma), or alpha-fetoprotein (AFP) ≥20 μg/L, or FibroScan®/FibroTouch® liver stiffness value (LSM)>10.6 kPa;
- Serum ceruloplasmin (CP) results suggest an increased risk of metabolic disease;
- Use of immunosuppressants within 6 months prior to first use of investigational product;
- Treatment with corticosteroids (other than topical or inhaled corticosteroids) lasting for 1 week or more within 6 months prior to first use of investigational product;
- Hepatitis C virus (HCV) antibody positive and HCV RNA positive; or hepatitis D virus (HDV) antibody positive; or human immunodeficiency virus (HIV) antibody positive; or Treponema pallidum (TP) antibody positive [except for rapid plasma reagin circular card test (RPR) or toluidine red unheated serum test (TRUST) negative];
- History of malignant tumor or recurrence within 5 years prior to the first use of investigational product;
- Previous organ transplant;
- Severe cardiac disease [including myocardial infarction, unstable angina, heart failure (New York Heart Association (NYHA) Functional Class III or IV, NYHA Functional Class criteria see Appendix 3)], renal failure, or pancreatitis;
- Diabetes mellitus with unstable drug control [glycosylated hemoglobin (HbA1c) ≥7.5%] or hypertension (systolic blood pressure ≥150 mmHg and/or diastolic blood pressure ≥100 mmHg);
- History of severe drug or food allergy;
- History of alcohol or drug abuse within 6 months prior to screening (mean alcohol consumption in ethanol: >40 g/day for men and>20 g/day for women);
- A past or current diagnosis of mental illness, especially depression or depressive tendencies;
- Use of other investigational drugs or biologics within 30 days or 5 drug half-lives (whichever is longer) prior to first use of investigational product; or participation in a clinical trial of a medical device, drug or vaccine at screening;
- Subjects who have previously taken the investigational drug TVAX-008 injection within 1 year;
- In the opinion of the investigator, participation in this trial is not appropriate due to other reasons.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multicenter, Randomized, Placebo-Controlled and Positive-Controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of TVAX-008 Injection in the Treatment of Chronic Hepatitis B
This is a multicenter, randomized, placebo-controlled (double-blind design) versus active-controlled (open-label design) Phase I clinical trial evaluating the efficacy and safety of TVAX-008 injection in subjects with chronic hepatitis B.
- Conditions
- Chronic hepatitisB
- Being tested
- TVAV-008, PegIFNα2b, Placeb
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TVAV-008Drug
TVAV-008 will be administered per 4 weeks
PegIFNα2bDrug
PegIFNα will be administered per week
PlacebDrug
Placebo will be administered per 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| TVAX-008 and placebo | Experimental | Not described Receives: Drug: TVAV-008; Drug: Placeb |
| PEG IFNα-2b | Active comparator | PEG IFNα-2b Receives: Drug: PegIFNα2b |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants achieving HBsAg lower than limit of detection (LOD) (0.05 IU/mL) and HBV DNA lower than lower limit of quantitation (LLOQ).
Measured: week72
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2025
- Study start31 Dec 2025 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic hepatitisBStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 630 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Grand Theravac Life Sciences (Nanjing) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07282249
- Sponsor's protocol ID
- YDSWX(TVAX-008)-003(III)
- Status last verified
- Nov 2025
- First submitted
- 30 Nov 2025
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Placebo-Controlled and Positive-Controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of TVAX-008 Injection in the Treatment of Chronic Hepatitis B
- ClinicalTrials.gov ID
- NCT07282249
- Acronym / sponsor ID
- YDSWX(TVAX-008)-003(III)
- Conditions
- Chronic hepatitisB
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 630 participants (estimated)
- Lead sponsor
- Grand Theravac Life Sciences (Nanjing) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Dec 2025 (estimated)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 15 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, randomized, placebo-controlled (double-blind design) versus active-controlled (open-label design) Phase I clinical trial evaluating the efficacy and safety of TVAX-008 injection in subjects with chronic hepatitis B.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TVAX-008 and placebo | Experimental | Drug: TVAV-008, Drug: Placeb |
| PEG IFNα-2b | Active comparator | Drug: PegIFNα2bPEG IFNα-2b |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female, aged 18 to 65 years (inclusive);
- Clinically diagnosed chronic hepatitis B (serum HBsAg positive ≥6 months);
- Subjects with a history of nucleoside (acid) analog anti-hepatitis B therapy lasting ≥6 months until screening, currently receiving antiviral therapy with a single nucleoside (acid) analog [eg, tenofovir fumarate (TAF), amitenofovir (TMF), tenofovir disoform fumarate (TDF) or entecavir (ETV), etc.], and HBV DNA<100 IU/mL within 28 days prior to the first dose of investigational product;
- Hepatitis B virus e antigen (HBeAg) negative within 28 days prior to first use of investigational product;
- HBsAg>0.05 IU/mL and HBsAg<100 IU/mL within 28 days prior to first use of investigational product;
Key exclusion criteria (28 listed)
- Liver disease caused by other causes, including alcoholic liver disease, nonalcoholic steatohepatitis, drug-induced hepatitis, hemochromatosis, etc.;
- In addition to chronic hepatitis B, clinically important chronic diseases that, in the opinion of the investigator, make the patient unsuitable for participation in the study, including but not limited to thyroid disease requiring clinical intervention or clinically significant thyroid dysfunction, fundus disease (e.g. retinopathy), chronic lung disease with lung dysfunction, history of severe seizures or current use of antiepileptic drugs, immunodeficiency or autoimmune disease;
- Laboratory indicators or symptoms meet one or more of the following:
- Use of immunosuppressants within 6 months prior to first use of investigational product;
- Treatment with corticosteroids (other than topical or inhaled corticosteroids) lasting for 1 week or more within 6 months prior to first use of investigational product;
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 |
|---|---|---|
| TVAV-008TVAV-008 will be administered per 4 weeks | Drug | TVAX-008 and placebo |
| PegIFNα2bPegIFNα will be administered per week | Drug | PEG IFNα-2b |
| PlacebPlacebo will be administered per 4 weeks | Drug | TVAX-008 and placebo |
Primary outcome
Proportion of participants achieving HBsAg lower than limit of detection (LOD) (0.05 IU/mL) and HBV DNA lower than lower limit of quantitation (LLOQ).
Time frame: week72
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
- Individual participant dataSharing planned: No
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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TVAV-008, PegIFNα2b and Placeb in people with Chronic hepatitisB, run by Grand Theravac Life Sciences (Nanjing) Co., Ltd..
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 7 inclusion and 28 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: opening soon, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lina Chen, Doctor (086+19921306230, chenlina@theravac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants achieving HBsAg lower than limit of detection (LOD) (0.05 IU/mL) and HBV DNA lower than lower limit of quantitation (LLOQ). (time frame: week72). 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 15 Dec 2025.