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Chronic Hepatitis BPhase 3NCT07797231

Clinical Trial of TQA3605 Tablet in Combination With Nucleos(t)Ide Analogues(NAs) Versus NAs Alone for the Treatment of Patients With Chronic Hepatitis B Virus Infection Who Have Undergone Treatment and Exhibit Low Viral Load or Poor Response

A Phase 3 study testing TQA3605 tablets, Entecavir dispersible tablets and Tenofovir Disoproxil Fumarate Tablets in people with Chronic Hepatitis B, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 77 sites in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This is a multicenter, randomized, double-blind, placebo-controlled Phase III study with an open-label extension. The purpose is to evaluate efficacy and safety in adult patients with chronic hepatitis B virus infection who have received at least 12 months of NAs therapy, to demonstrate that TQA3605 Tablets combined… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Chronic Hepatitis B
What is being tested?
TQA3605 tablets, Entecavir dispersible tablets and Tenofovir Disoproxil Fumarate Tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
930 participants
Where
77 sitesChina
Study dates
Sep 2026to Oct 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

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

  • 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.

Who cannot join

  • 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).
Show all 19Show fewer
  • 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.

Trial locations and contacts

77 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Qing Xie, doctor contact

13651804273

xq10403@rjh.com.cn

Junqi Niu, Doctor contact

13756661205

junqiniu@aliyun.com

77 sites in 1 country

China77 sites

  • Anyang People's Hospital

    Anyang, Henan, 455000

    fangjie chen, Bachelor, 16637232481, iamcfj@qq.com

  • Bao Ji City People's Hospital （BaoJi Emergency Medical Center ）

    Baoji, Shaanxi, 722300

    Fuchun Jing, Doctor, 18609175079, fleming7798@126.com

  • Beijing Ditan Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100000

    Minghui li, doctor, 13693259096, wuhm2000@sina.com

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100010

    Jinghang Xu, Doctor, 13661195941, ddcatih@sina.com

  • Beijing Youan Hospital，Capital Medical University

    Beijing, Beijing Municipality, 100069

    Bin Xu, doctor, 13716830822, xubin1016@126.com

  • Hepatobiliary Hospital of Jilin Province

    Changchun, Jilin, 130000

    shurong liu, Bachelor's Degree, 13578670535, 2813794970@qq.com

  • The Second Hospital of Jilin University

    Changchun, Jilin, 130000

    Zhenjing Jin, Doctor, 13604310429, 759844822@qq.com

  • The first hospital of Jilin University

    Changchun, Jilin, 130400

    Junqi Niu, doctor, 13756661205, junqiniu@aliyun.com

  • Second Xiangya Hospital of Central South University

    Changsha, Hunan, 410125

    Yongfang Jiang, doctor, 13875858624, jiangyongfang@csu.edu.cn

  • Changzhi People's Hospital

    Changzhi, Shanxi, 046000

    Hong WU, Master, 13038060670, x26111249@163.com

  • Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital

    Chengdu, Sichuan, 610000

    Jianmei Lin, master, 18981838263, 1483586678@qq.com

  • Public Health Clinical Center of Chengdu

    Chengdu, Sichuan, 610066

    Li Zhu, bechelor, 13730803139, 673043401@qq.com

  • Chifeng Hospital

    Chifeng, Inner Mongolia, 024000

    huidong lu, Master, 15847387386, doctorluling@163.com

  • The Second Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400010

    peng hu, doctor, 13608338064, hp_cq@163.com

  • The Southwest Hospital of Amu

    Chongqing, Chongqing Municipality, 400038

    qing mao, doctor, 13594180020, qingmao@tmmu.edu.cn

  • Chongqing University Three Gorges Hospital

    Chongqing, Chongqing Municipality, 404000

    Guicheng Wu, Doctor, 13896208811, 13896208811@163.com

  • Dalian Public Health Clinical Center

    Dalian, Liaoning, 116021

    gongchen wang, doctor, 18004266010, 15909862690@139.com

  • Deyang People's Hospital

    Deyang, Sichuan, 618000

    Xuebing chen, Master, 13881088112, gscxb-11@163.com

  • Nanhai District People's Hospital of Foshan

    Foshan, Guangdong, 528000

    yongchun Li, doctor, 13425661266, splyc@126.com

  • Mengchao Hepatobiliary Hospital of Fujian Medical University

    Fuzhou, Fujian, 350007

    Haibing Gao, Doctor, 13159438353, gaohb605@163.com

  • The Third Affiliated Hospital of Sun Yat-sen University

    Guangzhou, Guangdong, 510630

    Liang Peng, Doctor, 13533978874, pliang@mail.sysu.edu.cn

  • Guizhou Provincial People's Hospital

    Guiyang, Guizhou, 550002

    Hong Peng, Doctor, 13885035037, penghonggz@126.com

  • Hainan Provincial People's Hospital

    Haikou, Hainan, 570311

    Jian Fu, Bachelor's Degree, 13876371288, 13876371288@163.com

  • The First Affiliated Hospital Zhejiang University School Of Medicine

    Hangzhou, Zhejiang, 310006

    Yida Yang, doctor, 13857121518, yangyida65@163.com

  • The Fourth Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150000

    lei yu, doctor, 13804535357, ganranke@126.com

  • Harbin Medical University, The Second Affiliated Hospital

    Harbin, Heilongjiang, 150001

    Ming Liang, Doctor, 13936368393, lm19780816@126.com

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui, 230001

    YuFeng Gao, doctor, 13956938032, aygyf@126.com

  • The First Affiliated Hospital of Ustc（Anhui Provincial Hospital）

    Hefei, Anhui, 230001

    HongLiang HE, doctor, 15956927046, 44271370@qq.com

  • The First Affiliated Hospital Of University Of South China

    Hengyang, Hunan, 421001

    Zhongtian Peng, Master, 13873488377, hncspzt@163.com

  • The General Hospital of Hunan University of Medicine

    Huaihua, Hunan, 418000

    YongZhong Li, Bachelor's Degree, 15096257715, liyz2008@163.com

  • Shandong Public Health Clinical Center

    Jinan, Shandong, 250100

    Xiaoying Li, Master, 18765870708, 18765870708@126.com

  • Jingzhou Central Hospital

    Jingzhou, Hubei, 434036

    Qin Ming Hu, Bachelor of Medicine, 18107167200, 13508610186@163.com

  • The First Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan, 650032

    Jinghua Fan, Doctor, 13577093765, 429596667@qq.com

  • Hebei Petro China Central Hospital

    Langfang, Hebei, 065000

    Meili GAO, Bachelor, 13831653827, 594957495@qq.com

  • The First Hospital of Lanzhou University

    Lanzhou, Gansu, 730000

    Liting Zhang, doctor, 13993173526, Icheneye@163.com

  • Liaocheng People's Hospital

    Liaocheng, Shandong, 252000

    Fenghua Liu, Master, 13346253998, 13346253998@163.com

  • Lishui People's Hospital

    Lishui, Zhejiang, 323000

    Jiaojian Lv, bachelor, 18957091505, lslvjiaojian@163.com

  • Liuzhou Worker's Hospital

    Liuzhou, Guangxi, 545000

    Qian GUO, Master, 13978009767, 13978009767@139.com

  • Shanxi province fenyang hospital

    Lüliang, Shanxi, 032209

    YaoWu Zhang, Master, 15035899899, zyw5680@126.com

  • Luoyang Central Hospital（Luoyang Central Hospital Affiliated to Zhengzhou University）

    Luoyang, Henan, 471000

    Guotao Li, Master, 18537919499, 13837955056@139.com

  • Meishan People's Hospital

    Meishan, Sichuan, 620000

    Hui Deng, Bachelor, 13778888362, 3431281705@qq.com

  • Mudanjiang Kang'an Hospital

    Mudanjiang, Heilongjiang, 157011

    Xiqiu Zeng, master, 18645753000, mdjzengxiqiu@126.com

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

    Xiaoping Wu, Doctor, 13330122823, wuxiaoping2823@aliyun.com

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 333000

    shuilin Sun, Master, 13803500270, sunshuilin2280@126.com

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210000

    Li Dong, Doctor, 13512501015, Lilid1973@sina.com

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu, 210008

    Jie Li, doctor, 15863787910, lijier@sina.com

  • The Second Hospital of Ningbo

    Ningbo, Zhejiang, 315010

    yunsong Qian, Bachelor's degree, 13645740222, qianyuns@163.com

  • Puyang People's Hospital

    Puyang, Henan, 457000

    wenjing Dou, Master, 15839335025, 695284544@qq.com

  • Qingdao Municipal Hospital

    Qingdao, Shandong, 266011

    Yongning Xin, doctor, 18661678200, xinyongning@163.com

  • Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200000

    Qing Xie, doctor, 13651804273, xq10403@rjh.com.cn

  • Shanghai East Hospital

    Shanghai, Shanghai Municipality, 200120

    LiHong Qu, doctor, 18916510601, 18916510601@163.com

  • Shanghai Pudong Hospital

    Shanghai, Shanghai Municipality, 200120

    Wujun Xiong, Doctor, 13916617586, xiongwujun@126.com

  • Shanghai Pudong New Area Gongli Hospital

    Shanghai, Shanghai Municipality, 200135

    Shi Yi Hai, doctor, 18918157268, 732791146@qq.com

  • Shanghai Sixth People's Hospital

    Shanghai, Shanghai Municipality, 200233

    XiaoHua Chen, doctor, 18930172758, chenxiaohua2000@163.com

  • The Sixth People's Hospital of Shenyang

    Shenyang, Liaoning, 110002

    xiaofeng wu, Master, 18502460852, wy@mail.sy.ln.cn

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning, 110022

    yang ding, doctor, 13332434847, yding0903@sina.com

  • Peking University Shenzhen Hospital

    Shenzhen, Guangdong, 518000

    Guoxin Hu, Doctor of Medicine, 13823608228, huguoxin8228@sina.com

  • Shijiazhuang Fifth Hospital

    Shijiazhuang, Hebei, 050024

    Wenfang Yuan, Bachelor, 13313019790, 413699442@qq.com

    Huanwei Zheng, Doctor, 13323119317, 13323119317@163.com

  • The Fifth People's Hospital of Suzhou

    Suzhou, Jiangsu, 215100

    Chuanwu Zhu, Doctor, 13606202525, zhuchw@126.com

  • Shanxi Provincial People's Hospital

    Taiyuan, Shanxi, 030000

    Jing Feng, Doctor, 13753104039, fengjing791120@126.com

  • Taizhou Hospital Of Zhejiang Province

    Taizhou, Zhejiang, 318000

    Jiansheng Zhu, Master, 13806561595, zhujs@enzemed.com

  • Tianjin First Central Hospital

    Tianjin, Tianjin Municipality, 300380

    fengmei wang, doctor, 15522242696, wangfengmeitj@126.com

  • The First Affiliated Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang, 830063

    Xiaobo lu, doctor, 159 9917 6213‬‬‬‬‬‬‬‬, Xjykdluxiaobo@126.com

  • The Fourth Affiliated Hospital of Xinjiang Medical University (Traditional Chinese Medical Hospital of Xinjiang Uygur Autonomous Region)

    Ürümqi, Xinjiang, 830063

    xiaozhong wang, Master degree, 13809950758, wxz125@sina.com

  • Weifang People's Hospital

    Weifang, Shandong, 261000

    Jianhong Chen, Master, 13864629070, Chenjh328@163.com

  • Ruian People's Hospital

    Wenzhou, Zhejiang, 325200

    Liang Hong, bachelor, 13958805550, YahoshongLiang@163.com

  • The First Affiliated Hospital of Wannan Medical College / Yijishan Hospital of Wannan Medical College

    Wuhu, Anhui, 241001

    Jianghua Yang, Doctor, 13470751925, yjhpath@163.com

  • Gansu Wuwei Tumour Hospital

    Wuwei, Gansu, 730000

    Wenhua Zhang, Bachelor, 18993531188, 925944468@qq.com

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

    Xi'an, Shaanxi, 710000

    Yingli He, Doctor, 18991232863, Heyingli2000@163.com

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi, 710000

    Shuangsuo Dang, Doctor, 13992896471, dang212@123.com

  • Zhongshan Hospital, Xiamen University

    Xiamen, Fujian, 361004

    Hongzhi Xu, Doctor, 13606000360, Xuhongzhi07@163.com

  • The 4'th People's Hospital of Qinghai Province

    Xining, Qinghai, 810000

    Hongmei Zu, doctor, 13997384855, 13997384855@163.com

  • Yuncheng Central Hospital

    Yuncheng, Shanxi, 044000

    Lijun Chang, Master of medicine, 13453938813, clj881@126.com

  • The Sixth People's Hospital of Zhengzhou

    Zhengzhou, Henan, 450000

    Guangming Li, master, 13603715881, lgm177@sina.com

  • The first affiliated hospital of Zhengzhou university

    Zhengzhou, Henan, 450052

    Juan li, Doctor, 18595825852, ananli1984@126.com

  • The Fifth Affiliated Hospital of Sun Yat-sen University

    Zhuhai, Guangdong, 519000

    Zhongsi Hong, Master, 13926931110, 13926931110@163.com

  • Affiliated Hospital of Zunyi Medical University

    Zunyi, Guizhou, 563000

    yu yi, Master, 18786912014, 823357828@qq.com

Other trials in China

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled Phase III Trial With an Open-Label Extension to Evaluate the Efficacy and Safety of TQA3605 Tablets in Chronic Hepatitis B Virus-Infected Patients With Low-Level Viremia or Suboptimal Response After at Least 12 Months of NAs Therapy

This is a multicenter, randomized, double-blind, placebo-controlled Phase III study with an open-label extension. The purpose is to evaluate efficacy and safety in adult patients with chronic hepatitis B virus infection who have received at least 12 months of NAs therapy, to demonstrate that TQA3605 Tablets combined with oral nucleos(t)ide analogues can improve efficacy with satisfactory safety profile compared with oral nucleos(t)ide analogues alone in this population. Approximately 930 adult patients with chronic hepatitis B virus infection who have received at least 12 months of NAs therapy are planned to be enrolled in this study.

Being tested
TQA3605 tablets Placebo, TQA3605 tablets, Entecavir dispersible tablets, Tenofovir Disoproxil Fumarate Tablets, Tenofovir Alafenamide Fumarate Tablets
Medical subject headings
Hepatitis B, Chronic

What participants receive

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

  • TQA3605 tablets PlaceboDrug

    Placebo contains no active substance.

  • TQA3605 tabletsDrug

    TQA3605 tablets are core protein allosteric modulators

  • Entecavir dispersible tabletsDrug

    Entecavir dispersible tablets are a type of nucleoside analog antiviral drug.

  • Tenofovir Disoproxil Fumarate TabletsDrug

    Tenofovir Disoproxil Fumarate (TDF) is a nucleoside reverse transcriptase inhibitor.

  • Tenofovir Alafenamide Fumarate TabletsDrug

    Tenofovir Alafenamide Fumarate (TAF) is a nucleoside reverse transcriptase inhibitor.

  • Tenofovir Amibufenamide TabletsDrug

    Tenofovir Amibufenamide (TMF) is a phosphoramidate prodrug of tenofovir and belongs to nucleos(t)ide reverse transcriptase inhibitors.

Study groups in NCT07797231
Study groupRoleWhat they receive
TQA3605 Tablets + NAsExperimentalTQA3605 Tablets 100 mg once daily (QD) plus NAs administered for 96 weeks. Following completion of the 96-week treatment period, participants will continue NAs therapy with an 8-week follow-up.
Receives: Drug: TQA3605 tablets; Drug: Entecavir dispersible tablets; Drug: Tenofovir Disoproxil Fumarate Tablets; Drug: Tenofovir Alafenamide Fumarate Tablets; Drug: Tenofovir Amibufenamide Tablets
TQA3605 Tablets Placebo + NAsPlacebo comparatorTQA3605 tablets placebo, once daily, combined with NAs for 48 weeks. After the 48-week double-blind period, all trial participants received TQA3605 tablets, 100mg each time, QD, combined with NAs for another 48 weeks. After the 96-week treatment, NAs treatment was continued for an 8-week follow-up
Receives: Drug: TQA3605 tablets Placebo; Drug: TQA3605 tablets; Drug: Entecavir dispersible tablets; Drug: Tenofovir Disoproxil Fumarate Tablets; Drug: Tenofovir Alafenamide Fumarate Tablets; Drug: Tenofovir Amibufenamide Tablets

What is being measured

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

  1. HBV DNA

    Difference in the percentage of trial participants achieving HBV DNA less than 10 IU/mL after 48 weeks of treatment between the treatment group and the control group

    Measured: 48 weeks

Secondary outcomes (9)

  1. HBV DNA

    Percentage of trial participants with HBV DNA less than 10 IU/mL at each visit (excluding Week 48)

    Measured: Baseline to week 104

  2. HBV DNA

    Percentage of trial participants with HBV DNA less than 20 IU/mL at each visit

    Measured: Baseline to week 104

  3. HBsAg

    Percentage of trial participants with HBsAg less than 0.05 IU/mL;

    Measured: Baseline to week 104

  4. HBeAg

    Percentage of trial participants achieving HBeAg seroclearance and/or seroconversion

    Measured: Baseline to week 104

  5. Alanine aminotransferase(ALT)

    ALT normalization rate over time (ALT ≤ ULN) in trial participants with ALT > ULN at baseline without administration of liver-protective and transaminase-lowering agents

    Measured: Baseline to week 104

  6. Virology breakthrough

    Percentage of trial participants experiencing virologic breakthrough at each visit

    Measured: Baseline to week 104

  7. HBV markers

    Actual values of HBsAg, HBeAg, HBV DNA, HBV RNA, and HBcrAg at each visit time point and their changes over time relative to baseline

    Measured: Baseline to week 104

  8. Adverse events (AE)

    The incidence and severity of adverse events and serious adverse events

    Measured: From screening to Week 104

  9. Steady state minimum concentration (Cmin,ss)

    Cmin,ss of TQA3605 and its metabolite

    Measured: 48 weeks

Timeline

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

  1. First posted1 Sep 2026
  2. Study startSep 2026 (estimated)
  3. Primary completionSep 2028 (estimated)
  4. Study completionOct 2029 (estimated)

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
930 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07797231
Sponsor's protocol ID
TQA3605-III-01
Status last verified
Jul 2026
First submitted
28 Aug 2026
Last updated
2 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TQA3605 tablets, Entecavir dispersible tablets and Tenofovir Disoproxil Fumarate Tablets in people with Chronic Hepatitis B, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 77 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 7 inclusion and 19 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: opening soon, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 77 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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

Contact Qing Xie, doctor (13651804273, xq10403@rjh.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HBV DNA (time frame: 48 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 NCT07797231.

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 2 Oct 2026.

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