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

Phase 2Active Not RecruitingNCT07179653

Grand Theravac Life Sciences (Nanjing) Co., Ltd.48 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

HBV Infection

Interventions

TVAX-008DRUG

TVAX-008

PlaceboDRUG

Placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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;

Locations (1)

NanFang Hospital

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

HBsAg clearance rate

Time frame: Week49

Data from ClinicalTrials.gov

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