Evaluate TQ-A3334 Combined Nucleoside (Acid) Analogs in the First Treatment/Treatment of Chronic HBV Infection
Evaluate TQ-A3334 Tablets Combined Nucleoside (Acid) Analogs in the Initial Treatment/Chronic Hepatitis B Virus (HBV) Infection Subjects of Chronic HBV Infection
1 other identifier
interventional
116
1 country
15
Brief Summary
This study uses random, double -blindness, placebo control, and phase multi -center test design. All subjects who meet the standards receive TQ-A3334 per tablet/placebo nucleoside (acid) analog. A total of 116 subjects are needed.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Dec 2024
Shorter than P25 for phase_2
15 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
November 20, 2024
CompletedFirst Posted
Study publicly available on registry
November 26, 2024
CompletedStudy Start
First participant enrolled
December 4, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 22, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
CompletedNovember 26, 2025
November 1, 2025
7 months
November 20, 2024
November 21, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
At 24 weeks, the changes in serum HBSAG relative to the baseline
Evaluate the subject of chronic HBV infection in the early treatment/treatment of chronic HBV infection, TQ-A3334 combined with oral nucleoside (acid) drugs comparative placebo and oral nucleoside (acid) drugs, can it significantly improve the treatment for 24 weeks Serum HBSAG relative to the changes in the baseline
Up to 24 weeks
Secondary Outcomes (18)
The incidence of adverse events（AEs）
Up to 48 weeks
Severity of adverse events (AEs)
Up to 48 weeks
Incidence of serious adverse events (SAEs)
Up to 48 weeks
Severity of serious adverse events（SAEs）
Up to 28 weeks
HBsAg<100 IU/ml and HBV DNA <20 IU/ml subject
Week 24, 48 weeks, 60 weeks, 72 weeks
- +13 more secondary outcomes
Study Arms (6)
TQ-A3334 tablets 0.2mg quaque die (QD), combined with nucleoside (acid) analogs (NAs)
ACTIVE COMPARATORTQA3334 tablets 0.2mg once a day 0.2 mg/time, 1 time/night, 48 weeks of administration; 1 time/day for combined medication, 72 weeks of administration; 72 weeks.
0.2mg quaque die (QD) placebo, combined with nucleoside (acid) analogs (NAs)
PLACEBO COMPARATORPlacebo tablets 0.2mg once a day,0.2 mg/time, 1 time/night, 48 weeks of administration; 1 time/day for combined medication, 72 weeks of administration; 72 weeks.
TQ-A3334 tablets 0.5mg once the next day(QOD), combined with nucleoside (acid) analogs (NAs)
ACTIVE COMPARATORTQA333 tablets 0.5mg once the next day once the next day, administration for 48 weeks; combined medication 1/day, 72 weeks of administration.
Placebo 0.5mg once the next day (QOD) , combined with nucleoside (acid) analogs (NAs)
PLACEBO COMPARATORPlacebo 0.5mg once the next day, administration for 48 weeks; combined medication 1/day, 72 weeks of administration;
TQ-A3334 tablets 0.5mg quaque die (QD), combined with nucleoside (acid) analogs (NAs)
ACTIVE COMPARATORTQA3334 tablets 0.5mg once a day, 1/night, 48 weeks of administration; 1 time/day for combined medication, 72 weeks of administration; 72 weeks.
Placebo 0.5mg quaque die (QD) combined with nucleoside (acid) analogs (NAs)
PLACEBO COMPARATORPlacebo 0.5mg once a day, 1/night, 48 weeks of administration; 1 time/day for combined medication, 72 weeks of administration; 72 weeks.
Interventions
Placebo contains no active substance.
Inhibit viral replication.
Inhibit viral replication.
Eligibility Criteria
You may qualify if:
- 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;
- 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)
You may not qualify if:
- 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;
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016, China
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510000, China
Peking University Shenzhen Hospital
Shenzhen, Guangdong, 518036, China
Hospital workers in Liuzhou
Liuchow, Guangxi, 545000, China
WuHan Jinyintan Hospital
Wuhan, Hubei, 430023, China
The Second XIANGYA Hospital Of Central South University
Changsha, Hunan, 410008, China
The Fifth People's Hospital of Wuxi (Affiliated Wuxi Fifth Hospital of Jiangnan University)
Wuxi, Jiangsu, 214001, China
The first hospital of Jilin University
Changchun, Jilin, 130021, China
The Sixth People's Hospital of Shenyang
Shenyang, Liaoning, 110000, China
The First Affiliated Hospital of Xi'an Jiao Tong University
Xi'an, Shaanxi, 710000, China
West China Hospital of Sichuan University
Chengdu, Sichuan, 610044, China
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 831400, China
First People's Hospital of Yunnan Province
Kunming, Yunnan, 650034, China
Pu'er People's Hospital
Pu'er, Yunnan, 665099, China
People's Hospital Of RuiAn City
Rui’an, Zhejiang, 325200, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention 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
November 20, 2024
First Posted
November 26, 2024
Study Start
December 4, 2024
Primary Completion
June 22, 2025
Study Completion
June 1, 2026
Last Updated
November 26, 2025
Record last verified: 2025-11