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

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

Status and phase: Active, not recruiting; Phase 2

Conditions: HBV Infection

Treatments: Drug: Placebo; Drug: TVAX-008

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07179653

YDSWX(TVAX-008)-005(II)

Details and patient eligibility

About

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.

Enrollment: 48 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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48 participants in 2 patient groups, including a placebo group

TVAX-008

Experimental group

Treatment:

Drug: TVAX-008

placebo

Placebo Comparator group

Treatment:

Drug: Placebo