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Clinical Trial to Evaluate the Efficacy and Safety of TVAX-008 Injection in the Treatment of Chronic Hepatitis B

NCT07282249 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 630

Last updated 2025-12-15

No results posted yet for this study

Summary

This is a multicenter, randomized, placebo-controlled (double-blind design) versus active-controlled (open-label design) Phase I clinical trial evaluating the efficacy and safety of TVAX-008 injection in subjects with chronic hepatitis B.

Conditions

  • Chronic hepatitisB

Interventions

DRUG

TVAV-008

TVAV-008 will be administered per 4 weeks

DRUG

PegIFNα2b

PegIFNα will be administered per week

DRUG

Placeb

Placebo will be administered per 4 weeks

Sponsors & Collaborators

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

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-31
Primary Completion
2027-04-30
Completion
2027-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07282249 on ClinicalTrials.gov