Study Stopped
Per sponsor request. Premature closure was not prompted by any safety or efficacy concerns.
A Clinical Trial to Evaluate the Efficacy and Safety of TQA3605 Tablets in Treatment-naive Chronic HBV-infected Subjects
A Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of TQA3605 Tablets in Treatment-naive HBeAg-positive Subjects With Chronic HBV Infection
1 other identifier
interventional
N/A
1 country
29
Brief Summary
This is a multicenter, randomized, double-blind, placebo-controlled phase II study, in which all participants are required to use TQA3605 tablets/placebo in combination with entecavir. The purpose is to evaluate the efficacy and safety of TQA3605 tablets combined with entecavir in treatment-naive chronic HBV-infected subjects. A total of 215 subjects are required.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jul 2025
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 18, 2025
CompletedFirst Posted
Study publicly available on registry
May 25, 2025
CompletedStudy Start
First participant enrolled
July 9, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 17, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 17, 2025
CompletedAugust 3, 2025
February 1, 2025
8 days
May 18, 2025
July 30, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
hepatitis B virus (HBV) DNA <10 IU/mL
Percentage of subjects with HBV DNA below the lower limit of quantification (\<10 IU/mL) after 48 weeks of treatment.
48 weeks
Secondary Outcomes (8)
Percentage of subjects with HBV DNA<10 IU/mL
12 weeks, 24 weeks, 36 weeks, 60 weeks, 72 weeks
Percentage of HBV DNA<20 IU/mL
12 weeks, 24 weeks, 36 weeks, 48weeks, 60 weeks, 72 weeks
Percentage of subjects with HBeAg serologic clearance and/or serologic conversion
24weeks, 48 weeks, 72 weeks
Alanine aminotransferase(ALT)≤The upper limit of the normal reference value (ULN)
24weeks, 48 weeks, 72 weeks
Virology breakthrough percentage
24weeks, 48 weeks, 72 weeks
- +3 more secondary outcomes
Study Arms (5)
100mg TQA3605 tablets + entecavir (ETV) (PART A)
EXPERIMENTALPatients 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
200mg TQA3605 tablets +ETV (PART A)
EXPERIMENTALPatients 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 Placebo +ETV (PART A)
PLACEBO COMPARATORPatients 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.
200mg TQA3605 tablets +ETV (PART B)
EXPERIMENTALPatients 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 Placebo +ETV (PART B)
PLACEBO COMPARATORPatients 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.
Interventions
Placebo contains no active substance.
TQA3605 tablets is core protein allosteric modulators
Entecavir dispersible tablets is an inhibitor of hepatitis B virus replication.
Eligibility Criteria
You may qualify if:
- years old (including boundary values), regardless of gender;
- 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.
You may not qualify if:
- Pregnant (positive pregnancy test) or lactating women.
- 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;
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (29)
Beijing Ditan Hospital Capital Medical University
Beijing, Beijing Municipality, 100015, China
Beijing Youan Hospital,Capital Medical University
Beijing, Beijing Municipality, 100069, China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400010, China
The Southwest Hospital of AMU
Chongqing, Chongqing Municipality, 400038, China
Mengchao Hepatobiliary Hospital of Fujian Medical University
Fuzhou, Fujian, 350025, China
NanFang Hospital
Guangzhou, Guangdong, 510515, China
Peking University Shenzhen Hospital
Shenzhen, Guangdong, 518036, China
The First Affiliated Hospital of GUANGXI Medical University
Nanning, Guangxi, 530021, China
Hebei Medical University Third Hospital
Shijiazhuang, Hebei, 050000, China
Zhengzhou No.6 peoples Hospital
Zhengzhou, Henan, 450000, China
Henan Provincial People's Hospital
Zhengzhou, Henan, 450002, China
The First Hospital of Changsha
Changsha, Hunan, 410005, China
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu, 210003, China
The Second Hospital of Nanjing
Nanjing, Jiangsu, 210003, China
Naniing Drum Tower Hospital
Nanjing, Jiangsu, 210008, China
The Fifth People's Hospital of Suzhou
Suzhou, Jiangsu, 215131, China
The Fifth People's Hospital of Wuxi
Wuxi, Jiangsu, 214061, China
Zhenjiang Third People's Hospital
Zhenjiang, Jiangsu, 212004, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330000, China
The First Hospital of Jilin University
Changchun, Jilin, 130021, China
Shengjing Hospital Affiliated to China Medical University
Shenyang, Liaoning, Liaoning, China
The First Affiliated Hospital of Xi'an Jiao Tong University
Xi'an, Shaanxi, 710000, China
Xi'an Jiaotong University Second Affiliated Hospital
Xi'an, Shaanxi, 710000, China
The Second Hospital of Shandong University
Jinan, Shandong, 250033, China
Shandong Provincial Clinical Center for Public Health
Jinan, Shandong, 250102, China
Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200000, China
Shanghai Tongren Hospital
Shanghai, Shanghai Municipality, 200336, China
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830013, China
Yiwu Central Hospital
Yiwu, Zhejiang, 322099, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 18, 2025
First Posted
May 25, 2025
Study Start
July 9, 2025
Primary Completion
July 17, 2025
Study Completion
July 17, 2025
Last Updated
August 3, 2025
Record last verified: 2025-02