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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07179653

Enrollment

Registered

2025-09-18

Start date

2025-01-22

Completion date

2026-12-31

Last updated

2025-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HBV Infection

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 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.

Interventions

DRUGTVAX-008

TVAX-008

DRUGPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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;

Design outcomes

Primary

Measure	Time frame
HBsAg clearance rate	Week49

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026