New pill aims to silence hepatitis b virus in patients with stubborn Low-Level infection
NCT ID NCT06644417
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a new drug called TQA3605 in 122 adults with chronic hepatitis B who still had low levels of virus despite standard treatment. Participants took either TQA3605 or a placebo alongside their usual antiviral pills for 24 weeks. The goal was to see if adding TQA3605 could push the virus below detectable levels and improve safety.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- TQA3605 tablets (a core protein regulator)
- What this could lead to
- If successful, this could offer a new treatment option to help people with chronic hepatitis B achieve undetectable virus levels, potentially reducing liver damage and disease progression.
- What could go wrong
- This is an early-phase (Phase II) trial with only 122 participants, so results may not apply to everyone. The drug may not work better than current therapy, and side effects are still being studied.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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122 people
The number who actually took part.
- Started
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Nov 2024
- Finished
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Dec 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Beijing Ditan Hospital Capital Medical University
Beijing, Beijing Municipality, 100015, China
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Beijing Youan Hospital, Capital Medical Universitybeijing Institute of Hepatology
Beijing, Beijing Municipality, 100054, China
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Guizhou Provincial People's Hospital
Guiyang, Guizhou, 550002, China
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Jiangsu Provincial People's Hospital
Nanjing, Jiangsu, 210000, China
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Lishui People's Hospital
Lishui, Zhejiang, 323000, China
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Meng Chao Hepatobiliary Hospital of Fujian Medical University
Fuzhou, Fujian, 350001, China
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Peking University Shenzhen Hospital
Shenzhen, Guangdong, 518036, China
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Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200000, China
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Shandong Public Health Clinical Center
Jinan, Shandong, 250102, China
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Shanghai Tongren Hospital
Shanghai, Shanghai Municipality, 200336, China
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The Fifth People's Hospital of Suzhou
Suzhou, Jiangsu, 215131, China
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The First Affiliated Hospital Zhejiang University School Of Medicine
Hangzhou, Zhejiang, 310006, China
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The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330000, China
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The First Affiliated Hospital of Xi'an Jiao Tong University
Xi’an, Shanxi, 710000, China
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The Second XIANGYA Hospital Of Central South University
Changsha, Hunan, 410008, China
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The sixth people's Hospital Of Shenyang
Shenyang, Liaoning, 110001, China
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Yueyang Central Hospital
Yueyang, Hunan, 414000, China
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Zhengzhou No.6 peoples Hospital
Zhengzhou, Henan, 450000, China
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Zunyi Medical University Affiliated Hospital
Zunyi, Guizhou, 563000, China