A Clinical Trial to Evaluate the Efficacy and Safety of TQA3605 Tablets in Treatment-naive Chronic HBV-infected Subjects
NCT ID: NCT06990776
Last Updated: 2025-08-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2025-07-09
2025-07-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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100mg TQA3605 tablets + entecavir (ETV) (PART A)
Patients aged 30-65 years old group：TQA3605 tablets, 100mg once a day, orally for 48 weeks in combination with entecavir, followed by treatment with entecavir for 24 weeks
TQA3605 Tablets
TQA3605 tablets is core protein allosteric modulators
Entecavir dispersible tablets
Entecavir dispersible tablets is an inhibitor of hepatitis B virus replication.
200mg TQA3605 tablets +ETV (PART A)
Patients aged 30-65 years old group：TQA3605 tablets, 200mg once a day, orally for 48 weeks in combination with entecavir, followed by treatment with entecavir for 24 weeks
TQA3605 Tablets
TQA3605 tablets is core protein allosteric modulators
Entecavir dispersible tablets
Entecavir dispersible tablets is an inhibitor of hepatitis B virus replication.
TQA3605 tablets Placebo +ETV (PART A)
Patients aged 30-65 years old group： TQA3605 tablets placebo, once a day, orally for 48 weeks in combination with entecavir, followed by treatment with entecavir for 24 weeks.
TQA3605 tablets Placebo
Placebo contains no active substance.
200mg TQA3605 tablets +ETV (PART B)
Patients aged 18-30 years old group：TQA3605 tablets, 200mg once a day, orally for 48 weeks in combination with entecavir, followed by treatment with entecavir for 24 weeks.
TQA3605 Tablets
TQA3605 tablets is core protein allosteric modulators
Entecavir dispersible tablets
Entecavir dispersible tablets is an inhibitor of hepatitis B virus replication.
TQA3605 tablets Placebo +ETV (PART B)
Patients aged 18-30 years old group：TQA3605 tablets Placebo taken once a day, orally for 48 weeks in combination with entecavir, followed by treatment with entecavir for 24 weeks.
TQA3605 tablets Placebo
Placebo contains no active substance.
Interventions
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TQA3605 tablets Placebo
Placebo contains no active substance.
TQA3605 Tablets
TQA3605 tablets is core protein allosteric modulators
Entecavir dispersible tablets
Entecavir dispersible tablets is an inhibitor of hepatitis B virus replication.
Eligibility Criteria
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Inclusion Criteria
* Screening requires virological , clinical or pathological evidence of hepatitis B virus infection for more than 6 months; HBsAg positive, HBeAg positive, ALT≤5×ULN at screening;
* Never received nucleoside (acid) analog or interferon treatment, or previously received no more than 12 weeks of treatment but had discontinued therapy at least 6 months prior to the screening visit;
* Ability to communicate effectively with researchers and understand and comply with the requirements of this study, understand and sign the informed consent form;
* Male subjects with female partners who have fertility or female subjects of childbearing age are willing to voluntarily adopt effective contraceptive measures screening to within 3 months after leaving the group.
Exclusion Criteria
* Co-infection with other viruses such as Hepatitis A Virus (HAV), Hepatitis C Virus (HCV), Hepatitis D Virus (HDV), Hepatitis E Virus (HEV), Human Immunodeficiency Virus (HIV), Syphilis, etc.;
* History of cirrhosis or evidence of significant fibrosis or cirrhosis before or during screening;
* History of hepatocellular carcinoma (HCC) or suspected HCC before or during screening.;
* History of malignant tumors within the past 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, Wilson's disease, Gilbert syndrome, etc;
* Previous organ or bone marrow transplantation;
* Clinically significant abnormal laboratory test results at screening.
* Poorly controlled thyroid diseases or clinically significant thyroid dysfunction;
* Autoimmune diseases;
* Significant systemic or major illnesses other than liver disease.
* Any systemic anti-tumor or immunosuppressive therapy, or immunomodulatory therapy within 6 months prior to screening.
* High-dose systemic corticosteroids use within 3 months prior to screening;
* History of alcohol or drug abuse within the past year or excessive alcohol consumption.
* History of blood transfusion within 2 months prior to screening;
* History of allergy to investigational drug or its excipients.
* Previously participated in the clinical trial of hepatitis B core protein allosteric modulators;
* Participation in another clinical trial and receipt of an investigational drug within the following timeframes before the first dose in this study: 5 half-lives (if known) or twice the duration of the biological effect of the study treatment (if known), whichever is longer, or 90 days (if the half-life or duration is unknown);
* History or condition of cardiovascular disease;
* Any other condition deemed inappropriate for inclusion by the investigator.
18 Years
65 Years
ALL
No
Sponsors
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Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Beijing Ditan Hospital Capital Medical University
Beijing, Beijing Municipality, China
Beijing Youan Hospital,Capital Medical University
Beijing, Beijing Municipality, China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
The Southwest Hospital of AMU
Chongqing, Chongqing Municipality, China
Mengchao Hepatobiliary Hospital of Fujian Medical University
Fuzhou, Fujian, China
NanFang Hospital
Guangzhou, Guangdong, China
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China
The First Affiliated Hospital of GUANGXI Medical University
Nanning, Guangxi, China
Hebei Medical University Third Hospital
Shijiazhuang, Hebei, China
Zhengzhou No.6 peoples Hospital
Zhengzhou, Henan, China
Henan Provincial People's Hospital
Zhengzhou, Henan, China
The First Hospital of Changsha
Changsha, Hunan, China
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu, China
The Second Hospital of Nanjing
Nanjing, Jiangsu, China
Naniing Drum Tower Hospital
Nanjing, Jiangsu, China
The Fifth People's Hospital of Suzhou
Suzhou, Jiangsu, China
The Fifth People's Hospital of Wuxi
Wuxi, Jiangsu, China
Zhenjiang Third People's Hospital
Zhenjiang, Jiangsu, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
The First Hospital of Jilin University
Changchun, Jilin, China
Shengjing Hospital Affiliated to China Medical University
Shenyang, Liaoning, China
The First Affiliated Hospital of Xi'an Jiao Tong University
Xi'an, Shaanxi, China
Xi'an Jiaotong University Second Affiliated Hospital
Xi'an, Shaanxi, China
The Second Hospital of Shandong University
Jinan, Shandong, China
Shandong Provincial Clinical Center for Public Health
Jinan, Shandong, China
Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
Shanghai Tongren Hospital
Shanghai, Shanghai Municipality, China
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China
Yiwu Central Hospital
Yiwu, Zhejiang, China
Countries
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Other Identifiers
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TQA3605-II-02
Identifier Type: -
Identifier Source: org_study_id
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