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

NCT07190742 | Active Not Recruiting Phase 2

• 1 other identifier: YDSWX(TVAX-008)-002(II)
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• HBsAg negative conversion rate

  HBsAg negative conversion rate

  week37

Study Arms (2)

TVAX-008

EXPERIMENTAL

TVAX-008

Drug: TVAX-008

placebo

PLACEBO COMPARATOR

placebo

Drug: Placebo

Interventions

TVAX-008 DRUG

TVAX-008

TVAX-008

Placebo DRUG

Placebo

placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Peking University first hospital

Beijing, 10000, China

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2025
• First Posted: September 24, 2025
• Study Start: June 1, 2023
• Primary Completion: October 17, 2024
• Study Completion: May 1, 2026
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)