NCT07179653

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for phase_2

Timeline
7mo left

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress69%
Jan 2025Dec 2026

Study Start

First participant enrolled

January 22, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 11, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 18, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

September 18, 2025

Status Verified

September 1, 2025

Enrollment Period

10 months

First QC Date

September 11, 2025

Last Update Submit

September 11, 2025

Conditions

HBV Infection

Outcome Measures

Primary Outcomes (1)

  • HBsAg clearance rate

    Week49

Study Arms (2)

TVAX-008

EXPERIMENTAL
Drug: TVAX-008

placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

TVAX-008DRUG

TVAX-008

TVAX-008
PlaceboDRUG

Placebo

placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NanFang Hospital

Guangzhou, Guangdong, 20000, China

Location

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2025

First Posted

September 18, 2025

Study Start

January 22, 2025

Primary Completion

December 1, 2025

Study Completion (Estimated)

December 1, 2026

Last Updated

September 18, 2025

Record last verified: 2025-09

Locations

CN(1)