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New drug combo aims to tame chronic hepatitis b

NCT ID NCT06706310

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

116 people

The number who actually took part.

Started

Dec 2024

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

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

18 to 65 years

Sex

Anyone

Healthy volunteers

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

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

  • First People's Hospital of Yunnan Province

    Kunming, Yunnan, 650034, China

  • Hospital workers in Liuzhou

    Liuzhou, Guangxi, 545000, China

  • Peking University Shenzhen Hospital

    Shenzhen, Guangdong, 518036, China

  • People's Hospital Of RuiAn City

    Rui’an, Zhejiang, 325200, China

  • Pu'er People's Hospital

    Pu'er, Yunnan, 665099, China

  • The Fifth People's Hospital of Wuxi (Affiliated Wuxi Fifth Hospital of Jiangnan University)

    Wuxi, Jiangsu, 214001, China

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400016, China

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

    Xi'an, Shaanxi, 710000, China

  • The First Affiliated Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang, 831400, China

  • The Second XIANGYA Hospital Of Central South University

    Changsha, Hunan, 410008, China

  • The Sixth People's Hospital of Shenyang

    Shenyang, Liaoning, 110000, China

  • The Third Affiliated Hospital of Sun Yat-sen University

    Guangzhou, Guangdong, 510000, China

  • The first hospital of Jilin University

    Changchun, Jilin, 130021, China

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610044, China

  • WuHan Jinyintan Hospital

    Wuhan, Hubei, 430023, China

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