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

NCT ID: NCT07179653

Last Updated: 2025-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-22

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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HBV Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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TVAX-008

Group Type EXPERIMENTAL

TVAX-008

Intervention Type DRUG

TVAX-008

placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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TVAX-008

TVAX-008

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Eligibility Criteria

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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;
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role collaborator

Sichuan Provincial People's Hospital

OTHER

Sponsor Role collaborator

Meng Chao Hepatobiliary Hospital of Fujian Medical University

OTHER

Sponsor Role collaborator

Ruijin Hospital

OTHER

Sponsor Role collaborator

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

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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NanFang Hospital

Guangzhou, Guangdong, China

Site Status

Countries

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China

Other Identifiers

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YDSWX(TVAX-008)-005(II)

Identifier Type: -

Identifier Source: org_study_id

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