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

January 23, 2026 updated by: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
122

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100015
        • Beijing Ditan Hospital Capital Medical University
      • Beijing, Beijing Municipality, China, 100054
        • Beijing Youan Hospital, Capital Medical Universitybeijing Institute of Hepatology
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Meng Chao Hepatobiliary Hospital of Fujian Medical University
    • Guangdong
      • Shenzhen, Guangdong, China, 518036
        • Peking University Shenzhen Hospital
    • Guizhou
      • Guiyang, Guizhou, China, 550002
        • Guizhou Provincial People's Hospital
      • Zunyi, Guizhou, China, 563000
        • Zunyi Medical University Affiliated Hospital
    • Henan
      • Zhengzhou, Henan, China, 450000
        • Zhengzhou No.6 peoples Hospital
    • Hunan
      • Changsha, Hunan, China, 410008
        • The second Xiangya hospital of central south university
      • Yueyang, Hunan, China, 414000
        • Yueyang Central Hospital
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • Jiangsu Provincial People's Hospital
      • Suzhou, Jiangsu, China, 215131
        • The Fifth People's Hospital of Suzhou
    • Jiangxi
      • Nanchang, Jiangxi, China, 330000
        • The First Affiliated Hospital of NanChang University
    • Liaoning
      • Shenyang, Liaoning, China, 110001
        • The Sixth People's Hospital of Shenyang
    • Shandong
      • Jinan, Shandong, China, 250102
        • Shandong Public Health Clinical Center
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200000
        • Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
      • Shanghai, Shanghai Municipality, China, 200336
        • Shanghai Tongren Hospital
    • Shanxi
      • Xi’an, Shanxi, China, 710000
        • The First Affiliated Hospital of Xi'an Jiao Tong University
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310006
        • The First Affiliated Hospital Zhejiang University School of Medicine
      • Lishui, Zhejiang, China, 323000
        • Lishui People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Ages 18-65 (including boundary values), male or female.
  • At the time of screening, etiological or clinical or pathological evidence of hepatitis B virus infection has been more than 1 year; HBsAg positive, 10 IU/mL <HBV DNA≤2000 IU/mL, ALT≤3×ULN (upper limit of normal); No obvious cirrhosis was found by the researchers.
  • Continuous administration of any nucleoside (acid) analogues for more than 1 year and a stable regimen of ≥6 months prior to screening.
  • Able to communicate well with researchers, understand and comply with the requirements of the study, understand and sign the informed consent.
  • Male subjects with fertile female partners or female subjects of childbearing age were willing to voluntarily take effective contraceptive measures within 3 months after screening.

Exclusion Criteria:

  • Pregnant (positive pregnancy test) or breastfeeding women.
  • Co-infection with other viruses such as hepatitis A virus, hepatitis C virus, hepatitis D virus, hepatitis E virus, human immunodeficiency virus, syphilis.
  • A history of cirrhosis or evidence of significant fibrosis or cirrhosis at pre-screening/screening time.
  • The subject had a history of hepatocellular carcinoma (HCC) before or at the time of screening, or was suspected of HCC.
  • A history of malignant tumors within 5 years prior to screening, except for certain cancers that can be completely cured by surgical resection.
  • Subjects with other chronic liver diseases, including but not limited to autoimmune liver disease, alcoholic liver disease, and hepatolenticular degeneration.
  • Have previously received organ transplantation and bone marrow transplantation.
  • Abnormal laboratory examination indicators that do not meet the requirements of the program during screening.
  • Poorly controlled thyroid disease, or clinically significant thyroid dysfunction.
  • Autoimmune diseases include but are not limited to: systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, sarcoidosis, psoriasis, autoimmune uveitis, etc.;
  • In addition to liver disease, there are significant systemic or major diseases, including recent congestive heart failure, unstable coronary heart disease, arterial revasodilation, respiratory disease, digestive disease, renal insufficiency, stroke, transient ischemic attack, organ transplantation, psychiatric disease, etc. Uncontrolled systemic disease: poor blood pressure control; Diabetes has poor blood sugar control.
  • Received any systemic antitumor (including radiation) or immunosuppressive therapy (including biological immune inhibitors), or immunomodulatory therapy (including non-biological immunomodulatory oral drugs) in the 6 months prior to screening.
  • Receiving high doses of systemic corticosteroids within 3 months prior to the screening period.
  • A history of alcohol and drug abuse within 1 year prior to the screening period.
  • Blood transfusion ≤2 months before screening and/or blood donation ≤1 month before screening. Note: Participants were not allowed to donate blood throughout the study period.
  • Have a history of allergy to the experimental drug or its excipients.
  • Participated in clinical trials of hepatitis B core protein allosteric regulators.
  • The subject has participated in a clinical trial and received the investigational drug during the period prior to the first administration of the study: 5 half-lives or twice the duration of the biological effect of the study treatment or 90 days (if the half-life or duration is unknown).
  • History or status of cardiovascular disease: history of risk factors for tip torsion ventricular tachycardia, including unexplained syncope, known long QT syndrome, heart failure, myocardial infarction, angina, or clinically significant abnormal laboratory tests. Family history of long QT syndrome or Brugada syndrome. The Electrocardiogram (ECG) showed clinically significant abnormalities. Heart Rate (HR)≤45 bpm.
  • Those that researchers believe should not be included.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: TQA3605 Placebo plus NAs
TQA3605 placebo plus NAs drug was administered for 24 weeks and NAs was continued until 32 weeks
Drug: TQA3605 Placebo plus NAs
Placebo without drug substance
Experimental: 100mg TQA3605 tablets plus NAs
100mg TQA3605 tablets plus NAs drug was administered for 24 weeks and NAs was continued until 32 weeks
Drug: TQA3605 tablets plus NAs
TQA3605 tablets is core protein regulator
Experimental: 200mg TQA3605 tablets plus NAs
200mg TQA3605 tablets plus NAs drug was administered for 24 weeks and NAs was continued until 32 weeks
Drug: TQA3605 tablets plus NAs
TQA3605 tablets is core protein regulator

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
HBV DNA (Hepatitis B virus Deoxyribonucleic Acid)
Time Frame: 24 weeks
Percentage of subjects with HBV DNA below the lower limit of quantitative detection (<10 IU/mL) at 24 weeks of treatment
24 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence and severity of Adverse events (AEs)
Time Frame: 32 weeks
The incidence and severity of AEs were determined by changes in physical examination, vital signs, electrocardiogram, and laboratory tests
32 weeks
Incidence and severity of serious adverse events (SAEs)
Time Frame: 32 weeks
The incidence and severity of SAEs were determined by changes in physical examination, vital signs, electrocardiogram, and laboratory tests
32 weeks
HBV DNA (<10 IU/mL)
Time Frame: Weeks 12, Weeks 16, Weeks 24, Weeks 28, Weeks 32
Percentage of subjects with HBV DNA below the lower limit of quantitative detection (<10 IU/mL)
Weeks 12, Weeks 16, Weeks 24, Weeks 28, Weeks 32
Hepatitis B e antigen (HBeAg) Serology
Time Frame: Weeks 12, Weeks 24, Weeks 32
Percentage of subjects with HBeAg serologic clearance and/or serologic conversion (for HBeAg positive at baseline only)
Weeks 12, Weeks 24, Weeks 32
Alanine Aminotransferase (ALT) relapse rate
Time Frame: Weeks 12, Weeks 24, Weeks 32
Renormalize ALT over time in subjects with baseline ALT>upper limit of normal (ULN) in the absence of enzyme-lowering Liver protection medicine
Weeks 12, Weeks 24, Weeks 32
Breakthroughs in virology
Time Frame: Weeks 12, Weeks 24, Weeks 32
Percentage of subjects with a virological breakthrough
Weeks 12, Weeks 24, Weeks 32
HBV RNA (Hepatitis B virus Ribonucleic Acid)
Time Frame: Weeks 12, Weeks 24, Weeks 32
Actual values and changes of HBV RNA over time relative to baseline
Weeks 12, Weeks 24, Weeks 32
(Cmax, ss) Steady-state maximum concentration
Time Frame: Day 1, Day 29, Day 57, Day 85, Day 113, Day 169
Steady-state maximum concentration of TQA3605
Day 1, Day 29, Day 57, Day 85, Day 113, Day 169
(Cmin, ss) Steady state minimum concentration
Time Frame: Day 1, Day 29, Day 57, Day 85, Day 113, Day 169
Steady-state minimum concentration of TQA3605
Day 1, Day 29, Day 57, Day 85, Day 113, Day 169
Actual values and changes of HbsAg (Hepatitis B Surface Antigen)
Time Frame: Weeks 12, Weeks 24, Weeks 32
Actual values and changes of HbsAg over time relative to baseline
Weeks 12, Weeks 24, Weeks 32
Actual values and changes of HBeAg
Time Frame: Weeks 12, Weeks 24, Weeks 32
Actual values and changes of HBeAg over time relative to baseline
Weeks 12, Weeks 24, Weeks 32
Actual values and changes of HBV DNA
Time Frame: Weeks 12, Weeks 24, Weeks 32
Actual values and changes of HBV DNA over time relative to baseline
Weeks 12, Weeks 24, Weeks 32
Actual values and changes of Human Hepatitis B virus core antigen - associated antigen (HbcrAg)
Time Frame: Weeks 12, Weeks 24, Weeks 32
Actual values and changes of HbcrAg over time relative to baseline
Weeks 12, Weeks 24, Weeks 32
HBV DNA (<10 IU/mL)
Time Frame: Weeks 12, Weeks 16, Weeks 28, Weeks 32
Percentage of subjects with HBV DNA below the lower limit of quantitative detection (<10 IU/mL)
Weeks 12, Weeks 16, Weeks 28, Weeks 32

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 14, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 25, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 10, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 14, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 14, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 16, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 26, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TQA3605-II-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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