NCT06990776

A Clinical Trial to Evaluate the Efficacy and Safety of TQA3605 Tablets in Treatment-naive Chronic HBV-infected Subjects

A Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of TQA3605 Tablets in Treatment-naive HBeAg-positive Subjects With Chronic HBV Infection

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, randomized, double-blind, placebo-controlled phase II study, in which all participants are required to use TQA3605 tablets/placebo in combination with entecavir. The purpose is to evaluate the efficacy and safety of TQA3605 tablets combined with entecavir in treatment-naive chronic HBV-infected subjects. A total of 215 subjects are required.

Conditions

• Chronic Hepatitis B

Interventions

Type	Name	Description
DRUG	TQA3605 tablets Placebo	Placebo contains no active substance.
DRUG	TQA3605 Tablets	TQA3605 tablets is core protein allosteric modulators
DRUG	Entecavir dispersible tablets	Entecavir dispersible tablets is an inhibitor of hepatitis B virus replication.

Timeline

• Start date: 2025-07-09
• Primary completion: 2025-07-17
• Completion: 2025-07-17
• First posted: 2025-05-25
• Last updated: 2025-08-03

Locations

29 sites across 1 country: China