A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of TVAX-008 Injection in Chronic Hepatitis B Patients

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 subjects with HBSAg levels of 0.05 to 100 IU/mL, including CHB patients previously treated with siRNA/ASO drugs and treatment-naive HBV infection.

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Key information

Conditions

HBV Infection

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

NanFang Hospital

Guangzhou, Guangdong, 20000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

aged 18~65 ； Serum HBsAg positive ≥ 6 months； HBeAg negative；

Exclusion criteria

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;

Treatment and study plan

TVAX-008

Drug

TVAX-008

Placebo

Drug

Placebo

Primary outcomes

HBsAg clearance rate

Time frame: Week49

Sponsors and collaborators

Lead sponsor

Grand Theravac Life Sciences (Nanjing) Co., Ltd.

Industry

Collaborators

Meng Chao Hepatobiliary Hospital of Fujian Medical University
Nanfang Hospital, Southern Medical University
Ruijin Hospital
Sichuan Provincial People's Hospital

Registry information

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2026
First posted: Sep 18, 2025
Registry last updated: Sep 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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