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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 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 930

Last updated 2026-09-03

No results posted yet for this study

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.

Conditions

Interventions

DRUG

TQA3605 tablets Placebo

Placebo contains no active substance.

DRUG

TQA3605 tablets

TQA3605 tablets are core protein allosteric modulators

DRUG

Entecavir dispersible tablets

Entecavir dispersible tablets are a type of nucleoside analog antiviral drug.

DRUG

Tenofovir Disoproxil Fumarate Tablets

Tenofovir Disoproxil Fumarate (TDF) is a nucleoside reverse transcriptase inhibitor.

DRUG

Tenofovir Alafenamide Fumarate Tablets

Tenofovir Alafenamide Fumarate (TAF) is a nucleoside reverse transcriptase inhibitor.

DRUG

Tenofovir Amibufenamide Tablets

Tenofovir Amibufenamide (TMF) is a phosphoramidate prodrug of tenofovir and belongs to nucleos(t)ide reverse transcriptase inhibitors.

Sponsors & Collaborators

  • Chia Tai Tianqing Pharmaceutical Group 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
2026-09-30
Primary Completion
2028-09-30
Completion
2029-10-31

Countries

  • China

Study Locations

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Entities

Diseases

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 NCT07797231 on ClinicalTrials.gov