drugset
drugset / Trial / NCT07797231

Clinical Trial of TQA3605 Tablet in Combination With Nucleos(t)Ide Analogues(NAs) Versus NAs Alone for the Treatment of Patients With Chronic Hepatitis B Virus Infection Who Have Undergone Treatment and Exhibit Low Viral Load or Poor Response

NCT07797231 ↗

Phase 3 Not yet recruiting 930 enrolled Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a multicenter, randomized, double-blind, placebo-controlled Phase III study with an open-label extension. The purpose is to evaluate efficacy and safety in adult patients with chronic hepatitis B virus infection who have received at least 12 months of NAs therapy, to demonstrate that TQA3605 Tablets combined with oral nucleos(t)ide analogues can improve efficacy with satisfactory safety profile compared with oral nucleos(t)ide analogues alone in this population. Approximately 930 adult patients with chronic hepatitis B virus infection who have received at least 12 months of NAs therapy are planned to be enrolled in this study.

Timeline

Start
2026-09
Primary completion
2028-09
Completion
2029-10

Drugs

EvaluationDrugModalityDoseRoute
Subject TQA3605 Unknown 100 mg —
Background Entecavir Small molecule — Oral
Background Tenofovir Amibufenamide Unknown — Oral
Background Tenofovir disoproxil fumarate Small molecule — Oral
Background tenofovir alafenamide Small molecule — Oral

Indications

chronic hepatitis B virus infection