Clinical Trial to Evaluate the Efficacy and Safety of TVAX-008 Injection in the Treatment of Chronic Hepatitis B

NCT07282249 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: YDSWX(TVAX-008)-003(III)
• Study Type: interventional
• Target: 630
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Chronic hepatitisB

Outcome Measures

Primary Outcomes (1)

• 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).

  week72

Study Arms (2)

TVAX-008 and placebo

EXPERIMENTAL

Drug: TVAV-008; Drug: Placeb

PEG IFNα-2b

ACTIVE COMPARATOR

PEG IFNα-2b

Drug: PegIFNα2b

Interventions

TVAV-008 DRUG

TVAV-008 will be administered per 4 weeks

TVAX-008 and placebo

PegIFNα2b DRUG

PegIFNα will be administered per week

PEG IFNα-2b

Placeb DRUG

Placebo will be administered per 4 weeks

TVAX-008 and placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Grand Theravac Life Sciences (Nanjing) Co., Ltd.: lead

Central Study Contacts

Lina Chen, Doctor

CONTACT

086+19921306230; chenlina@theravac.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2025
• First Posted: December 15, 2025
• Study Start: December 31, 2025
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 15, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share