NCT07282249

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

A Multicenter, Randomized, Placebo-Controlled and Positive-Controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of TVAX-008 Injection in the Treatment of Chronic Hepatitis B

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 630 (estimated)
• Sponsor: Grand Theravac Life Sciences (Nanjing) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2025-12-31
• Primary completion: 2027-04-30
• Completion: 2027-12-31
• First posted: 2025-12-15
• Last updated: 2025-12-15