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HBV Infection With LLVPhase 2NCT06644417

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 Phase 2 study testing TQA3605 tablets plus NAs in people with HBV Infection With LLV, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 19 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
HBV Infection With LLV
What is being tested?
TQA3605 tablets plus NAs
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
122 participants
Where
19 sitesChina
Study dates
14 Nov 2024to 10 Dec 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

19 sites in 1 country.

19 sites in 1 country

China19 sites

  • Beijing Ditan Hospital Capital Medical University

    Beijing, Beijing Municipality, 100015

  • Beijing Youan Hospital, Capital Medical Universitybeijing Institute of Hepatology

    Beijing, Beijing Municipality, 100054

  • The Second XIANGYA Hospital Of Central South University

    Changsha, Hunan, 410008

  • Meng Chao Hepatobiliary Hospital of Fujian Medical University

    Fuzhou, Fujian, 350001

  • Guizhou Provincial People's Hospital

    Guiyang, Guizhou, 550002

  • The First Affiliated Hospital Zhejiang University School Of Medicine

    Hangzhou, Zhejiang, 310006

  • Shandong Public Health Clinical Center

    Jinan, Shandong, 250102

  • Lishui People's Hospital

    Lishui, Zhejiang, 323000

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330000

  • Jiangsu Provincial People's Hospital

    Nanjing, Jiangsu, 210000

  • Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality, 200000

  • Shanghai Tongren Hospital

    Shanghai, Shanghai Municipality, 200336

  • The sixth people's Hospital Of Shenyang

    Shenyang, Liaoning, 110001

  • Peking University Shenzhen Hospital

    Shenzhen, Guangdong, 518036

  • The Fifth People's Hospital of Suzhou

    Suzhou, Jiangsu, 215131

  • The First Affiliated Hospital of Xi'an Jiao Tong University

    Xi’an, Shanxi, 710000

  • Yueyang Central Hospital

    Yueyang, Hunan, 414000

  • Zhengzhou No.6 peoples Hospital

    Zhengzhou, Henan, 450000

  • Zunyi Medical University Affiliated Hospital

    Zunyi, Guizhou, 563000

Other trials in China

About this study

Official title: 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.

Being tested
TQA3605 tablets plus NAs, TQA3605 Placebo plus NAs

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TQA3605 tablets plus NAsDrug

    TQA3605 tablets is core protein regulator

  • TQA3605 Placebo plus NAsDrug

    Placebo without drug substance

Study groups in NCT06644417
Study groupRoleWhat they receive
TQA3605 Placebo plus NAsPlacebo comparatorTQA3605 placebo plus NAs drug was administered for 24 weeks and NAs was continued until 32 weeks
Receives: Drug: TQA3605 Placebo plus NAs
100mg TQA3605 tablets plus NAsExperimental100mg TQA3605 tablets plus NAs drug was administered for 24 weeks and NAs was continued until 32 weeks
Receives: Drug: TQA3605 tablets plus NAs
200mg TQA3605 tablets plus NAsExperimental200mg TQA3605 tablets plus NAs drug was administered for 24 weeks and NAs was continued until 32 weeks
Receives: Drug: TQA3605 tablets plus NAs

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. HBV DNA (Hepatitis B virus Deoxyribonucleic Acid)

    Percentage of subjects with HBV DNA below the lower limit of quantitative detection (<10 IU/mL) at 24 weeks of treatment

    Measured: 24 weeks

Secondary outcomes (14)

  1. Incidence and severity of Adverse events (AEs)

    The incidence and severity of AEs were determined by changes in physical examination, vital signs, electrocardiogram, and laboratory tests

    Measured: 32 weeks

  2. Incidence and severity of serious adverse events (SAEs)

    The incidence and severity of SAEs were determined by changes in physical examination, vital signs, electrocardiogram, and laboratory tests

    Measured: 32 weeks

  3. HBV DNA (<10 IU/mL)

    Percentage of subjects with HBV DNA below the lower limit of quantitative detection (<10 IU/mL)

    Measured: Weeks 12, Weeks 16, Weeks 28, Weeks 32

  4. HBV DNA (<10 IU/mL)

    Percentage of subjects with HBV DNA below the lower limit of quantitative detection (<10 IU/mL)

    Measured: Weeks 12, Weeks 16, Weeks 24, Weeks 28, Weeks 32

  5. Hepatitis B e antigen (HBeAg) Serology

    Percentage of subjects with HBeAg serologic clearance and/or serologic conversion (for HBeAg positive at baseline only)

    Measured: Weeks 12, Weeks 24, Weeks 32

  6. Alanine Aminotransferase (ALT) relapse rate

    Renormalize ALT over time in subjects with baseline ALT>upper limit of normal (ULN) in the absence of enzyme-lowering Liver protection medicine

    Measured: Weeks 12, Weeks 24, Weeks 32

  7. Breakthroughs in virology

    Percentage of subjects with a virological breakthrough

    Measured: Weeks 12, Weeks 24, Weeks 32

  8. Actual values and changes of HbsAg (Hepatitis B Surface Antigen)

    Actual values and changes of HbsAg over time relative to baseline

    Measured: Weeks 12, Weeks 24, Weeks 32

  9. Actual values and changes of HBeAg

    Actual values and changes of HBeAg over time relative to baseline

    Measured: Weeks 12, Weeks 24, Weeks 32

  10. Actual values and changes of HBV DNA

    Actual values and changes of HBV DNA over time relative to baseline

    Measured: Weeks 12, Weeks 24, Weeks 32

  11. HBV RNA (Hepatitis B virus Ribonucleic Acid)

    Actual values and changes of HBV RNA over time relative to baseline

    Measured: Weeks 12, Weeks 24, Weeks 32

  12. Actual values and changes of Human Hepatitis B virus core antigen - associated antigen (HbcrAg)

    Actual values and changes of HbcrAg over time relative to baseline

    Measured: Weeks 12, Weeks 24, Weeks 32

  13. (Cmax, ss) Steady-state maximum concentration

    Steady-state maximum concentration of TQA3605

    Measured: Day 1, Day 29, Day 57, Day 85, Day 113, Day 169

  14. (Cmin, ss) Steady state minimum concentration

    Steady-state minimum concentration of TQA3605

    Measured: Day 1, Day 29, Day 57, Day 85, Day 113, Day 169

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Oct 2024
  2. Study start14 Nov 2024
  3. Primary completion25 Aug 2025
  4. Study completion10 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
122 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06644417
Sponsor's protocol ID
TQA3605-II-01
Status last verified
Dec 2025
First submitted
14 Oct 2024
Last updated
26 Jan 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TQA3605 tablets plus NAs in people with HBV Infection With LLV, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 19 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HBV DNA (Hepatitis B virus Deoxyribonucleic Acid) (time frame: 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06644417.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026.

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