New drug combo aims to tame chronic hepatitis b
NCT ID NCT06706310
First seen Jun 26, 2026 · Last updated Sep 11, 2026 · Updated 2 times
Summary
This Phase 2 trial tests whether adding TQ-A3334 tablets to standard nucleoside analog drugs can better control chronic hepatitis B. About 116 adults with the infection will receive either the combination or a placebo plus standard drugs. The main goal is to see if the combination lowers a key virus marker (HBsAg) in the blood after 24 weeks of treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- TQ-A3334 tablet combined with nucleoside analogs
- What this could lead to
- If successful, this combination could help control chronic hepatitis B more effectively, potentially reducing the virus's activity and improving liver health.
- What could go wrong
- This is an early Phase 2 trial with only 116 people, so results may not apply broadly. The treatment may not significantly lower HBsAg levels, 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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116 people
The number who actually took part.
- Started
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Dec 2024
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- 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: Those who meet all the selected standards below can enter the group test: * The subject can communicate well with the researchers and understand and comply with the various items in this study, understand and sign the consent of informed consent; * 18-65 years old (including the boundary value), and men and women are not limited (calculated based on the date of signing the consent of informedness); * Serum virus standard: serum HBSAG positive for more than 6 months or more than 6 months chronic Evidence of HBV infection. * No obvious liver cirrhosis is judged by researchers; Those who have been treated after treatment need to meet the following conditions: * The subject must receive oral nucleoside (acid) drug treatment before screening ≥6 months and the stable treatment plan before the screening period is ≥3 months; * Historian history records of the HBV DNA \<6 and above HBV DNA \<6) HBV DNA \<minimum detection lower limit. The initial governance subjects need to meet the following conditions: * If the preliminary governance subject does not have HBSAG positive for 6 months, researchers can make the knot according to the initial diagnosis Fruit, the clinical manifestations of the subjects, and the comprehensive judgment of the family history of hepatitis B family whether it is chronic infection; * The subjects have never received the treatment of chronic hepatitis B antiviral treatment (oral nucleoside drugs and interferon) at the time of screening; * The upper limit of the normal reference value (ULN) \<Alanine aminotransferase≤ 5 × ULN (within 2 weeks before the first medication) Exclusion Criteria: Anyone who appears below will not be able to enter the group test: * Pregnancy (pregnancy test is positive) or lactating women. * Combined other virus infections such as hepatitis A virus,hepatitis C virus, hepatitis D virus, hepatitis E virus, human immunodeficiency virus, syphilis (those with positive syphilis antibodies, and those who are judged by researchers) and so on. * History of liver cirrhosis or before screening/screening shows significant fibrosis or liver cirrhosis; or abdominal ultrasound examination prompts suspected liver cirrhosis; past liver dysfunction history or screening period has liver dysfunction compensation For those such as ascites, hepatic brain diseases, and esophageal stomach veins, bleeding; * The subject of Hepatocellular Carcinoma (HCC) before screening or at the time of screening has a history of Hepatocellular Carcinoma (HCC), or suspected HCC; * There is a history of malignant tumor diseases within the first 5 years of screening. Except for specific menstrual resection, it can be completely cured (such as skin basal cell carcinoma, etc.). * A subject with other chronic liver diseases, including but not limited to autoimmune liver disease, alcoholic liver disease, hepatolenticular degeneration, etc. * Organization and bone marrow transplantation have been accepted in the past. * Poor thyroid disease, or clinical thyroid dysfunction (TSH abnormal T3 or T4 abnormalities); * Eye disease: Including the bottom of the eye lesions (changes in the cotton samples with symptoms of the eye) and retinal lesions. * Autoimmune diseases include but are not limited to: systemic lupus erythematosus, rheumatoid arthritis, etc. * In addition to liver disease, there are obvious systemic or major diseases. * Any systemic anti -tumor (including radiation) or immunosuppressive treatment (including biomorphic inhibitors), or immunotherapies within 6 months before screening. * Blood transfusion within ≤ 2 months before screening and/or donate blood within 1 month before screening. Note: The subject must not donate blood during the entire study; * History of allergies to test medicines or its auxiliary materials; * Toll-like receptors-7, Toll-like receptors-8 receptor agonist or PD-1, PD-L1 similar drugs have been used within three months before screening. * The subject has participated in a clinical trial and accepted the test medicine for the test before the first time of the administration: 5 semi -half -life (such as known) or studying the duration of the biological effects (such as such as the duration of the biological effects (such as such as the duration of the biological effects (such as such as the duration of the biological effects (such as such as the duration of the biological effects (such as such as the duration of the biological effects (such as such as the duration of the biological effects (such as the duration of the biological effects (such as the duration of the biological effects (such as the duration of the biological effects (such as Two times (known) or 90 days (if the elderly prevails) or 90 days (if the half -life or duration is unknown). * History or condition of cardiovascular disease: History of risk factors for risk factors of cutting -out rooms, including miracles, known long QT syndrome, heart failure, myocardial infarction, angina pectoris, or clinical significance laboratory Examination (including hypokalemia, hypercalcemia, or hypomagnesemia). Long QT syndrome or BRUGADA syndrome family history. ECG shows abnormal clinical significance. Heart rate≤45 Secondary/minutes. * Researchers believe that those 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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First People's Hospital of Yunnan Province
Kunming, Yunnan, 650034, China
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Hospital workers in Liuzhou
Liuzhou, Guangxi, 545000, China
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Peking University Shenzhen Hospital
Shenzhen, Guangdong, 518036, China
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People's Hospital Of RuiAn City
Rui’an, Zhejiang, 325200, China
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Pu'er People's Hospital
Pu'er, Yunnan, 665099, China
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The Fifth People's Hospital of Wuxi (Affiliated Wuxi Fifth Hospital of Jiangnan University)
Wuxi, Jiangsu, 214001, China
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The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016, China
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The First Affiliated Hospital of Xi'an Jiao Tong University
Xi'an, Shaanxi, 710000, China
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The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 831400, 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, 110000, China
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The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510000, China
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The first hospital of Jilin University
Changchun, Jilin, 130021, China
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West China Hospital of Sichuan University
Chengdu, Sichuan, 610044, China
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WuHan Jinyintan Hospital
Wuhan, Hubei, 430023, China
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