NCT06644417

Clinical Study of TQA3605 Tablets Combined With Nucleoside (Acid) Analogs (NAs) Drugs Compared With NAs Drugs in the Treatment of Chronic Hepatitis B Virus (HBV) Infection

A Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of TQA3605 Tablets in Treated Subjects With Chronic HBV Infection With Low-level Viremia (LLV)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 122 (actual)
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study is a phase II multicenter, randomized, double-blind, placebo controlled study designed to evaluate the efficacy and safety in LLV subjects and demonstrate that TQA3605 tablets combined with oral NAs drugs can improve the efficacy and safety of LLV subjects compared with oral NAs drug.

Conditions

• HBV Infection With LLV

Interventions

Type	Name	Description
DRUG	TQA3605 tablets plus NAs	TQA3605 tablets is core protein regulator
DRUG	TQA3605 Placebo plus NAs	Placebo without drug substance

Timeline

• Start date: 2024-11-14
• Primary completion: 2025-08-25
• Completion: 2025-12-10
• First posted: 2024-10-16
• Last updated: 2026-01-26

Locations

19 sites across 1 country: China