Chronic Hepatitis B VirusPhase 2NCT07190742
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of TVAX-008 Injection in Treated Patients With Chronic Hepatitis B
A Phase 2 study testing TVAX-008 in people with Chronic Hepatitis B Virus, run by Grand Theravac Life Sciences (Nanjing) Co., Ltd. at 1 site in China.
Trial summary
The objective of this study was to evaluate the efficacy and safety of TVAX-008 Injection in a multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase II clinical trial in NAs-treated subjects with chronic hepatitis B. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Hepatitis B Virus
- What is being tested?
- TVAX-008
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2023to 1 May 2026
- Phase
- Phase 2
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Voluntary signing of the informed consent form, understanding of the study and willingness to follow and ability to complete all trial procedures;
- Male or female, age 18-65 (including thresholds)
- Clinically diagnosed chronic hepatitis B (HBsAg positive serum ≥6 months)
- 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
- 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
Who cannot join
- 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
- 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)
- 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
- Use of immunosuppressants within 6 months prior to first use of investigational product
- Treatment with corticosteroids (other than topical or inhaled corticosteroids) for 1 week or more within 6 months prior to first use of investigational product
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study was to evaluate the efficacy and safety of TVAX-008 Injection in a multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase II clinical trial in NAs-treated subjects with chronic hepatitis B. 80 subjects are planned to be enrolled in this study and divided into 2 groups. After a screening period of no more than 4 weeks, eligible subjects will be randomly assigned to enter the double-blind treatment period according to the ratio of 1:1, and receive TVAX-008 injection or placebo in combination with NAs for 24 weeks. At the end of the double-blind treatment period, subjects with HBsAg negative and HBsAg>100 mIU/mL continued to be followed up to Week 73; subjects with HBsAg not negative or HBsAg negative but HBsAg ≤100 mIU/mL entered the open-label treatment period and received TVAX-008 injection combined with NAs for 24 weeks, and continued to be followed up for 24 weeks after the end of the open-label treatment period.
- Conditions
- Chronic Hepatitis B Virus
- Being tested
- TVAX-008, Placebo
- 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.
TVAX-008Drug
TVAX-008
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| TVAX-008 | Experimental | TVAX-008 Receives: Drug: TVAX-008 |
| placebo | Placebo comparator | placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
HBsAg negative conversion rate
HBsAg negative conversion rate
Measured: week37
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2025
- Study start1 Jun 2023
- Primary completion17 Oct 2024
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis B VirusStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 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
- NCT07190742
- Sponsor's protocol ID
- YDSWX(TVAX-008)-002(II)
- Status last verified
- Sep 2025
- First submitted
- 17 Sep 2025
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of TVAX-008 Injection in Treated Patients With Chronic Hepatitis B
- ClinicalTrials.gov ID
- NCT07190742
- Acronym / sponsor ID
- YDSWX(TVAX-008)-002(II)
- Conditions
- Chronic Hepatitis B Virus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Grand Theravac Life Sciences (Nanjing) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 17 Oct 2024 (actual)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 24 Sep 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.
The objective of this study was to evaluate the efficacy and safety of TVAX-008 Injection in a multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase II clinical trial in NAs-treated subjects with chronic hepatitis B. 80 subjects are planned to be enrolled in this study and divided into 2 groups. After a screening period of no more than 4 weeks, eligible subjects will be randomly assigned to enter the double-blind treatment period according to the ratio of 1:1, and receive TVAX-008 injection or placebo in combination with NAs for 24 weeks. At the end of the double-blind treatment period, subjects with HBsAg negative and HBsAg>100 mIU/mL continued to be followed up to Week 73; subjects with HBsAg not negative or HBsAg negative but HBsAg ≤100 mIU/mL entered the open-label treatment period and received TVAX-008 injection combined with NAs for 24 weeks, and continued to be followed up for 24 weeks after the end of the open-label treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TVAX-008 | Experimental | Drug: TVAX-008TVAX-008 |
| placebo | Placebo comparator | Drug: Placeboplacebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Voluntary signing of the informed consent form, understanding of the study and willingness to follow and ability to complete all trial procedures;
- Male or female, age 18-65 (including thresholds)
- Clinically diagnosed chronic hepatitis B (HBsAg positive serum ≥6 months)
- 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
- HBeAg negative within 28 days prior to first use of investigational product
Key exclusion criteria (5 listed)
- 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
- 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)
- 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
- Use of immunosuppressants within 6 months prior to first use of investigational product
- Treatment with corticosteroids (other than topical or inhaled corticosteroids) 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 |
|---|---|---|
| TVAX-008TVAX-008 | Drug | TVAX-008 |
| PlaceboPlacebo | Drug | placebo |
Primary outcome
HBsAg negative conversion rate
Time frame: week37
HBsAg negative conversion rate
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 24 Sep 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TVAX-008 in people with Chronic Hepatitis B Virus, run by Grand Theravac Life Sciences (Nanjing) Co., Ltd. at 1 site in China.
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 6 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
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?
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?
HBsAg negative conversion rate (time frame: week37). 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 24 Sep 2025.