Can a new pill push hepatitis b virus to undetectable levels?

NCT ID NCT07797231

Disease control Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Source: ClinicalTrials.gov ↗

First seen Sep 01, 2026 · Last updated Sep 04, 2026 · Updated 3 times

Summary

This trial tests whether adding an experimental drug called TQA3605 to standard antiviral therapy helps more adults with chronic hepatitis B reach undetectable virus levels. About 930 participants who have been on antiviral treatment for at least a year will receive either TQA3605 or a placebo, alongside their usual medication. The study measures how many people achieve a viral load below 10 IU/mL after 48 weeks, and it also tracks safety and other markers of infection.

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, an experimental drug that targets the hepatitis B virus core protein, added to standard antiviral therapy
What this could lead to: If it works, adding TQA3605 to standard antivirals could help more people with chronic hepatitis B achieve undetectable virus levels, potentially lowering the risk of liver damage and improving long-term outcomes.
What could go wrong: This is a phase 3 trial, but success is not guaranteed. The drug may not outperform the placebo, and side effects are possible. The study focuses on virus suppression, not a cure, so treatment may need to continue.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 930 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Oct 2029

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: * Male or female participants aged 18-65 years (inclusive) at screening. * Able to communicate effectively with the investigator, understand and comply with all requirements of this study, and understand and sign the informed consent form. * Have received continuous treatment with nucleos(t)ide analogues (entecavir, tenofovir disoproxil fumarate, tenofovir alafenamide fumarate or tenofovir amibufenamide) or NAs combination therapy for ≥ 12 months at screening, with a stable single regimen for ≥ 6 months (medication adherence \> 90% in the past 12 months, with no treatment interruption exceeding 15 consecutive days). * Etiological evidence is available at screening to confirm chronic HBV infection of more than 1 year (HBsAg positive and/or HBV DNA positive for at least 1 year). * HBV DNA \> 50 IU/mL detected by a local medical institution within 30 days prior to screening, which is reconfirmed as HBV DNA \> 50 IU/mL by the central laboratory during the screening period. * HBeAg positive as confirmed by the central laboratory at screening. * Male trial participants with fertile female partners or female participants of childbearing potential are willing to use effective contraception from screening until 3 months after study discontinuation. Exclusion Criteria: * Pregnant women (positive pregnancy test) or breastfeeding women. * Co-infection with other viruses such as HAV, HCV, HDV, HEV, HIV, or syphilis (participants with positive syphilis antibody who require treatment as judged by the investigator; Participants with positive HCV antibody and negative HCV RNA may not be excluded). * History of liver cirrhosis; or liver histopathology obtained within 1 year prior to screening indicating Metavir ≥ S3, Scheuer ≥ S3 or Ishak ≥ S4; or FibroScan result ≥ 9.0 kPa within 6 months prior to screening; or previous endoscopy revealing esophageal and gastric varices; or suspected liver cirrhosis identified on abdominal ultrasonography at screening, such as ascites, hepatic encephalopathy, and bleeding from esophageal and gastric varices. * History of hepatocellular carcinoma (HCC) or suspected HCC at or prior to screening (e.g., suspicious lesions on imaging, or AFP ≥ 50 ng/mL). * History of malignant tumor within 5 years prior to screening, except for certain malignancies that are completely curable after surgical resection (e.g., basal cell carcinoma of the skin). Trial participants under evaluation for active or suspected malignant tumor at screening. * Trial participants with other chronic liver diseases, including but not limited to autoimmune liver disease, alcoholic liver disease, Wilson's disease, metabolic dysfunction-associated steatohepatitis (MASH). * Clinically significant abnormal laboratory parameters at screening (abnormal values may be retested once): Hematology: white blood cell count less than 3 ×10⁹/L, neutrophil count less than 1.5 ×10⁹/L, platelet count less than 100 ×10⁹/L, or hemoglobin less than 100 g/L. Biochemistry: estimated glomerular filtration rate (eGFR) calculated using the CKD-EPI formula ≤ 60 mL/min/1.73 m²; ALT or AST greater than 3 × ULN; total bilirubin greater than 2 × ULN; albumin less than 30 g/L; total cholesterol ≥ 7.75 mmol/L; triglycerides ≥ 3.42 mmol/L; serum uric acid greater than 420 μmol/L. Coagulation: international normalized ratio (INR) greater than 1.5.4) Antinuclear antibody (ANA) greater than 1:100 (indirect immunofluorescence, IIF). If ANA = 1:100, the investigator shall assess whether there is relevant medical history or symptoms of connective tissue disease or autoimmune disease. * Electrocardiogram showing clinically significant abnormalities at screening rendering the participant unsuitable for trial participation as judged by the investigator. * Autoimmune diseases including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, sarcoidosis, psoriasis, autoimmune uveitis. * Significant systemic or severe diseases other than liver disease, including recent (≤ 6 months prior to screening) congestive heart failure (New York Heart Association (NYHA) Functional Classification III-IV), unstable coronary artery disease, arterial revascularization, respiratory diseases, renal insufficiency, stroke, transient ischemic attack, organ transplantation, psychiatric disorders. Uncontrolled systemic diseases: poorly controlled hypertension (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg); poorly controlled diabetes (fasting plasma glucose (FPG) greater than 10 mmol/L). * Major trauma or major surgery within 3 months prior to screening, or planned surgery during the study period. * Received any systemic anti-tumor therapy (including radiotherapy), immunosuppressive therapy (including biological immunosuppressants), or immunomodulatory therapy within 6 months prior to screening (including oral non-biological immunomodulatory agents such as methotrexate greater than 25 mg/week, azathioprine greater than 3 mg/kg/day, or 6-mercaptopurine greater than 1.5 mg/kg/day). * Received high-dose systemic corticosteroids within 3 months prior to screening, defined as prednisone ≥ 40 mg/day for more than 7 consecutive days or prednisone ≥ 20 mg/day for more than 14 consecutive days. * History of drug dependence or substance abuse. * History of excessive alcohol consumption. Excessive alcohol consumption is defined as weekly ethanol intake exceeding 210 g for males and 140 g for females over the past 12 months. Ethanol intake (g) = Volume consumed (mL) × Alcohol by volume (%) × 0.8. * History of allergy to the investigational product or its excipients. * Previous participation in clinical trials of hepatitis B core protein allosteric modulators (CpAMs). * Participated in other clinical trials of investigational drugs or medical devices and received study intervention within 3 months prior to screening. * Participants deemed inappropriate for enrollment by the investigator.

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Conditions

The condition(s) this trial relates to.

chronic hepatitis B virus infection hepatitis B virus infection

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic hepatitis B

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

76 sites. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

Affiliated Hospital of Zunyi Medical University

Zunyi, Guizhou, 56300, China
Anyang People's Hospital

Anyang, Henan, 455000, China
Bao Ji City People's Hospital （BaoJi Emergency Medical Center ）

Baoji, Shaanxi, 722300, China
Beijing Ditan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100000, China
Beijing Youan Hospital，Capital Medical University

Beijing, Beijing Municipality, 100069, China
Chifeng Hospital

Chifeng, Inner Mongolia, 24000, China
Chongqing University Three Gorges Hospita

Chongqing, Chongqing Municipality, 404000, China
Dalian Public Health Clinical Center

Dalian, Liaoning, 116021, China
Deyang People's Hospital

Deyang, Sichuan, 618000, China
Gansu Wuwei Tumour Hospital

Wuwei, Gansu, 730000, China
Guizhou Provincial People's Hospital

Guiyang, Guizhou, 550002, China
Hainan Provincial People's Hospital

Haikou, Hainan, 570311, China
Harbin Medical University, The Second Affiliated Hospital

Harbin, Heilongjiang, 150001, China
Hebei Petro China Central Hospital

Langfang, Hebei, 65000, China
Hepatobiliary Hospital of Jilin Province

Changchun, Jilin, 130000, China
Jiangsu Province Hospital

Nanjing, Jiangsu, 210000, China
Jingzhou Central Hospital

Jingzhou, Hubei, 434036, China
Liaocheng People's Hospital

Liaocheng, Shandong, 252000, China
Lishui People's Hospital

Lishui, Zhejiang, 323000, China
Liuzhou Worker's Hospital

Liuzhou, Guangxi, 545000, China
Luoyang Central Hospital（Luoyang Central Hospital Affiliated to Zhengzhou University）

Luoyang, Henan, 471000, China
Meishan People's Hospital

Meishan, Sichuan, 620000, China
Mengchao Hepatobiliary Hospital of Fujian Medical University

Fuzhou, Fujian, 350007, China
Mudanjiang Kang'an Hospital

Mudanjiang, Heilongjiang, 157011, China
Nanhai District People's Hospital of Foshan

Foshan, Guangdong, 528000, China
Nanjing Drum Tower Hospital

Nanjing, Jiangsu, 210008, China
Peking University First Hospital

Beijing, Beijing Municipality, 100010, China
Peking University Shenzhen Hospital

Shenzhen, Guangdong, 518000, China
Public Health Clinical Center of Chengdu

Chengdu, Sichuan, 610066, China
Puyang People's Hospital

Puyang, Henan, 457000, China
Qingdao Municipal Hospital

Qingdao, Shandong, 266011, China
Ruian People's Hospital

Wenzhou, Zhejiang, 325204, China
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200000, China
Second Xiangya Hospital of Central South University

Changsha, Hunan, 410125, China
Shandong Public Health Clinical Center

Jinan, Shandong, 250100, China
Shanghai East Hospital

Shanghai, Shanghai Municipality, 200120, China
Shanghai Pudong Hospital

Shanghai, Shanghai Municipality, 200120, China
Shanghai Pudong New Area Gongli Hospital

Shanghai, Shanghai Municipality, 200135, China
Shanghai Sixth People's Hospital

Shanghai, Shanghai Municipality, 200233, China
Shanxi Provincial People's Hospital

Taiyuan, Shanxi, 030000, China
Shanxi province fenyang hospita

Lüliang, Shanxi, 33000, China
Shengjing Hospital of China Medical University

Shenyang, Liaoning, 110022, China
Shijiazhuang Fifth Hospital

Shijiazhuang, Hebei, 050024, China
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital

Chengdu, Sichuan, 610000, China
Taizhou Hospital Of Zhejiang Province

Taizhou, Zhejiang, 318000, China
The 4'th People's Hospital of Qinghai Province

Xining, Qinghai, 810000, China
The Fifth Affiliated Hospital of Sun Yat-sen University

Zhuhai, Guangdong, 519000, China
The Fifth People's Hospital of Suzhou

Suzhou, Jiangsu, 215100, China
The First Affiliated Hospital Of University Of South China

Hengyang, Hunan, 421001, China
The First Affiliated Hospital Zhejiang University School Of Medicine

Hangzhou, Zhejiang, 310006, China
The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230001, China
The First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, 650032, China
The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330006, China
The First Affiliated Hospital of Ustc（Anhui Provincial Hospital）

Hefei, Anhui, 230001, China
The First Affiliated Hospital of Wannan Medical College / Yijishan Hospital of Wannan Medical College

Wuhu, Anhui, 241001, 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, 830063, China
The First Hospital of Lanzhou University

Lanzhou, Gansu, 730000, China
The Fourth Affiliated Hospital of Xinjiang Medical University (Traditional Chinese Medical Hospital of Xinjiang Uygur Autonomous Region)

Ürümqi, Xinjiang, 830063, China
The Fourth Hospital of Harbin Medical University

Harbin, Heilongjiang, 150000, China
The General Hospital of Hunan University of Medicine

Huaihua, Hunan, 418000, China
The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 40000, China
The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 333000, China
The Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710000, China
The Second Hospital of Jilin University

Changchun, Jilin, 130000, China
The Second Hospital of Ningbo

Ningbo, Zhejiang, 315010, China
The Sixth People's Hospital of Shenyang

Shenyang, Liaoning, 110002, China
The Sixth People's Hospital of Zhengzhou

Zhengzhou, Henan, 450000, China
The Southwest Hospital of Amu

Chongqing, Chongqing Municipality, 400038, China
The Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510630, China
The first affiliated hospital of Zhengzhou university

Zhengzhou, Henan, 450052, China
The first hospital of Jilin University

Changchun, Jilin, 130400, China
Tianjin First Central Hospital

Tianjin, Tianjin Municipality, 300380, China
Weifang People's Hospital

Weifang, Shandong, 261000, China
Yuncheng Central Hospital

Yuncheng, Shanxi, 044000, China
Zhongshan Hospital, Xiamen University

Xiamen, Fujian, 361004, China

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