Chronic Hepatitis BPhase 2NCT06706310
Evaluate TQ-A3334 Combined Nucleoside (Acid) Analogs in the First Treatment/Treatment of Chronic HBV Infection
A Phase 2 study testing TQA3334 Tablet and Nucleoside (acid) analogs (NAs) in people with Chronic Hepatitis B, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 15 sites in China.
Trial 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. 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?
- TQA3334 Tablet and Nucleoside (acid) analogs (NAs)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 116 participants
- Where
- 15 sitesChina
- Study dates
- 4 Dec 2024to Dec 2026
- Phase
- Phase 2
- 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
- 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;
- 18-65 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:
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- 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)
Who cannot join
- 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.).
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- 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;
- Toll-like receptors-7, Toll-like receptors-8 receptor agonist or PD-1, PD-L1 similar drugs have been used within three months before screening.
- The subject has participated in a clinical trial and accepted the test medicine for the test before the first time of the administration: 5 semi -half -life (such as known) or studying the duration of the biological effects (such as such as the duration of the biological effects (such as such as the duration of the biological effects (such as such as the duration of the biological effects (such as such as the duration of the biological effects (such as such as the duration of the biological effects (such as such as the duration of the biological effects (such as the duration of the biological effects (such as the duration of the biological effects (such as the duration of the biological effects (such as Two times (known) or 90 days (if the elderly prevails) or 90 days (if the half -life or duration is unknown).
- History or condition of cardiovascular disease: History of risk factors for risk factors of cutting -out rooms, including miracles, known long QT syndrome, heart failure, myocardial infarction, angina pectoris, or clinical significance laboratory Examination (including hypokalemia, hypercalcemia, or hypomagnesemia). Long QT syndrome or BRUGADA syndrome family history. ECG shows abnormal clinical significance. Heart rate≤45 Secondary/minutes.
- Researchers believe that those should not be included.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
China15 sites
The first hospital of Jilin University
Changchun, Jilin, 130021
The Second XIANGYA Hospital Of Central South University
Changsha, Hunan, 410008
West China Hospital of Sichuan University
Chengdu, Sichuan, 610044
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510000
First People's Hospital of Yunnan Province
Kunming, Yunnan, 650034
Hospital workers in Liuzhou
Liuzhou, Guangxi, 545000
Pu'er People's Hospital
Pu'er, Yunnan, 665099
People's Hospital Of RuiAn City
Rui’an, Zhejiang, 325200
The Sixth People's Hospital of Shenyang
Shenyang, Liaoning, 110000
Peking University Shenzhen Hospital
Shenzhen, Guangdong, 518036
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 831400
WuHan Jinyintan Hospital
Wuhan, Hubei, 430023
The Fifth People's Hospital of Wuxi (Affiliated Wuxi Fifth Hospital of Jiangnan University)
Wuxi, Jiangsu, 214001
The First Affiliated Hospital of Xi'an Jiao Tong University
Xi'an, Shaanxi, 710000
About this study
Official title: Evaluate TQ-A3334 Tablets Combined Nucleoside (Acid) Analogs in the Initial Treatment/Chronic Hepatitis B Virus (HBV) Infection Subjects of Chronic HBV Infection
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.
- Conditions
- Chronic Hepatitis B
- Being tested
- Placebo, TQA3334 Tablet, Nucleoside (acid) analogs (NAs)
- 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.
PlaceboDrug
Placebo contains no active substance.
TQA3334 TabletDrug
Inhibit viral replication.
Nucleoside (acid) analogs (NAs)Drug
Inhibit viral replication.
| Study group | Role | What they receive |
|---|---|---|
| TQ-A3334 tablets 0.2mg quaque die (QD), combined with nucleoside (acid) analogs (NAs) | Active comparator | TQA3334 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. Receives: Drug: TQA3334 Tablet; Drug: Nucleoside (acid) analogs (NAs) |
| 0.2mg quaque die (QD) placebo, combined with nucleoside (acid) analogs (NAs) | Placebo comparator | Placebo 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. Receives: Drug: Placebo; Drug: Nucleoside (acid) analogs (NAs) |
| TQ-A3334 tablets 0.5mg once the next day(QOD), combined with nucleoside (acid) analogs (NAs) | Active comparator | TQA333 tablets 0.5mg once the next day once the next day, administration for 48 weeks; combined medication 1/day, 72 weeks of administration. Receives: Drug: TQA3334 Tablet; Drug: Nucleoside (acid) analogs (NAs) |
| Placebo 0.5mg once the next day (QOD) , combined with nucleoside (acid) analogs (NAs) | Placebo comparator | Placebo 0.5mg once the next day, administration for 48 weeks; combined medication 1/day, 72 weeks of administration; Receives: Drug: Placebo; Drug: Nucleoside (acid) analogs (NAs) |
| TQ-A3334 tablets 0.5mg quaque die (QD), combined with nucleoside (acid) analogs (NAs) | Active comparator | TQA3334 tablets 0.5mg once a day, 1/night, 48 weeks of administration; 1 time/day for combined medication, 72 weeks of administration; 72 weeks. Receives: Drug: TQA3334 Tablet; Drug: Nucleoside (acid) analogs (NAs) |
| Placebo 0.5mg quaque die (QD) combined with nucleoside (acid) analogs (NAs) | Placebo comparator | Placebo 0.5mg once a day, 1/night, 48 weeks of administration; 1 time/day for combined medication, 72 weeks of administration; 72 weeks. Receives: Drug: Placebo; Drug: Nucleoside (acid) analogs (NAs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 24 weeks
Secondary outcomes (18)
The incidence of adverse events（AEs）
To investigate the incidence of adverse events (AEs) during treatment
Measured: Up to 48 weeks
Severity of adverse events (AEs)
To study the severity of adverse events (AEs) during treatment
Measured: Up to 48 weeks
Incidence of serious adverse events (SAEs)
To investigate the incidence of serious adverse events (SAEs) during treatment
Measured: Up to 48 weeks
Severity of serious adverse events（SAEs）
To investigate the severity of serious adverse events (SAEs) during treatment
Measured: Up to 28 weeks
HBsAg<100 IU/ml and HBV DNA <20 IU/ml subject
The proportion of subjects of HBsAg<100 IU/ml and HBV DNA <20 IU/ml.
Measured: Week 24, 48 weeks, 60 weeks, 72 weeks
HBSAG self -based lines drop ≥0.5, ≥1 Log10IU/ml
Awarded by HBSAG's self -base line decrease ≥0.5, ≥1 Log10IU/ml.
Measured: Week 24, 48 weeks, 60 weeks, 72 weeks
The proportion of subjects of HBSAG serological removal and/or serum transformation during the study period
HBSAG serum science clearance and/or serum transition ratio proportion
Measured: Week 24, 48 weeks, 60 weeks, 72 weeks
The proportion of subjects of HBEAG serological removal and/or serum conversion during the study period
The proportion of subjects of HBEAG serological removal and/or serum transformation during the study.
Measured: Week 24, 48 weeks, 60 weeks, 72 weeks
Peak time (Tmax)
Time to peak blood concentration after a single dose.
Measured: Day1 0 hour pre-dose,10,20,30minutes,1,2,3,6,12,24,48 hours after dose, Day15 within 60 minutes pre-dose, Day29 0h pre-dose,10, 20, 30 minutes, 1,2,3,6,12,24,48 hours after dose, Day57 and Day85 0hour pre-dose
Peak Concentration
The highest plasma drug concentration that can be achieved after medication.
Measured: Day1 0 hour pre-dose,10,20,30minutes,1,2,3,6,12,24,48 hours after dose, Day15 within 60 minutes pre-dose, Day29 0h pre-dose,10, 20, 30 minutes, 1,2,3,6,12,24,48 hours after dose, Day57 and Day85 0hour pre-dose
Area under blood concentration-time curve (AUC)
The amount of drug absorbed into the human circulation after a single dose can be estimated using the area under the blood concentration-time curve.
Measured: Day1 0 hour pre-dose,10,20,30minutes,1,2,3,6,12,24,48 hours after dose, Day15 within 60 minutes pre-dose, Day29 0h pre-dose,10, 20, 30 minutes, 1,2,3,6,12,24,48 hours after dose, Day57 and Day85 0hour pre-dose
Apparent volume of distribution (Vd/F)
When a drug reaches homeostasis in the body, the ratio of the amount of drug in the body to the blood concentration is called the apparent volume of distribution
Measured: Day1 0 hour pre-dose,10,20,30minutes,1,2,3,6,12,24,48 hours after dose, Day15 within 60 minutes pre-dose, Day29 0h pre-dose,10, 20, 30 minutes, 1,2,3,6,12,24,48 hours after dose, Day57 and Day85 0hour pre-dose
Plasma clearance
How many milliliters of plasma can the kidneys completely clear in unit time (per minute)
Measured: Day1 0 hour pre-dose,10,20,30minutes,1,2,3,6,12,24,48 hours after dose, D15 within 60 minutes pre-dose, Day29 0h pre-dose,10, 20, 30 minutes, 1,2,3,6,12,24,48 hours after dose, D57 and D85 0hour pre-dose.
Elimination half-life time
The time it takes for the plasma concentration to drop by half.
Measured: Day1 0 hour pre-dose,10,20,30minutes,1,2,3,6,12,24,48 hours after dose, Day15 within 60 minutes pre-dose, Day29 0h pre-dose,10, 20, 30 minutes, 1,2,3,6,12,24,48 hours after dose, Day57 and Day85 0hour pre-dose
Peaking Time
The time required to reach peak steady-state concentration after administration.
Measured: Day1 0 hour pre-dose,10,20,30minutes,1,2,3,6,12,24,48 hours after dose, D15 within 60 minutes pre-dose, Day29 0h pre-dose,10, 20, 30 minutes, 1,2,3,6,12,24,48 hours after dose, D57 and D85 0hour pre-dose.
Steady state maximum concentration
The highest blood concentration that occurs after stabilization.
Measured: Day1 0 hour pre-dose,10,20,30minutes,1,2,3,6,12,24,48 hours after dose, Day15 within 60 minutes pre-dose, Day29 0h pre-dose,10, 20, 30 minutes, 1,2,3,6,12,24,48 hours after dose, Day57 and Day85 0hour pre-dose
Steady state minimal concentration
The lowest blood concentration that occurs after stabilization
Measured: Day1 0 hour pre-dose,10,20,30minutes,1,2,3,6,12,24,48 hours after dose, Day15 within 60 minutes pre-dose, Day29 0h pre-dose,10, 20, 30 minutes, 1,2,3,6,12,24,48 hours after dose, Day57 and Day85 0hour pre-dose
Area under steady-state blood concentration-time curve
After the dosage of a single agent, the amount of dosage of the blood circulation of the person can be used with blood concentration-the area of the area under the time curve.
Measured: Day1 0 hour pre-dose,10,20,30minutes,1,2,3,6,12,24,48 hours after dose, Day15 within 60 minutes pre-dose, Day29 0h pre-dose,10, 20, 30 minutes, 1,2,3,6,12,24,48 hours after dose, Day57 and Day85 0hour pre-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study start4 Dec 2024
- Primary completion7 Dec 2025
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis BStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06706310
- Sponsor's protocol ID
- TQ-A3334-II-03
- Status last verified
- Sep 2026
- First submitted
- 20 Nov 2024
- Last updated
- 11 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate TQ-A3334 Tablets Combined Nucleoside (Acid) Analogs in the Initial Treatment/Chronic Hepatitis B Virus (HBV) Infection Subjects of Chronic HBV Infection
- ClinicalTrials.gov ID
- NCT06706310
- Acronym / sponsor ID
- TQ-A3334-II-03
- Conditions
- Chronic Hepatitis B
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Dec 2024 (actual)
- Primary completion
- 7 Dec 2025 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 26 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| TQ-A3334 tablets 0.2mg quaque die (QD), combined with nucleoside (acid) analogs (NAs) | Active comparator | Drug: TQA3334 Tablet, Drug: Nucleoside (acid) analogs (NAs)TQA3334 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 comparator | Drug: Placebo, Drug: Nucleoside (acid) analogs (NAs)Placebo 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 comparator | Drug: TQA3334 Tablet, Drug: Nucleoside (acid) analogs (NAs)TQA333 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 comparator | Drug: Placebo, Drug: Nucleoside (acid) analogs (NAs)Placebo 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 comparator | Drug: TQA3334 Tablet, Drug: Nucleoside (acid) analogs (NAs)TQA3334 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 comparator | Drug: Placebo, Drug: Nucleoside (acid) analogs (NAs)Placebo 0.5mg once a day, 1/night, 48 weeks of administration; 1 time/day for combined medication, 72 weeks of administration; 72 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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;
- 18-65 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;
- 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;
Key exclusion criteria (19 listed)
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboPlacebo contains no active substance. | Drug | 0.2mg quaque die (QD) placebo, combined with nucleoside (acid) analogs (NAs), Placebo 0.5mg once the next day (QOD) , combined with nucleoside (acid) analogs (NAs), Placebo 0.5mg quaque die (QD) combined with nucleoside (acid) analogs (NAs) |
| TQA3334 TabletInhibit viral replication. | Drug | TQ-A3334 tablets 0.2mg quaque die (QD), combined with nucleoside (acid) analogs (NAs), TQ-A3334 tablets 0.5mg once the next day(QOD), combined with nucleoside (acid) analogs (NAs), TQ-A3334 tablets 0.5mg quaque die (QD), combined with nucleoside (acid) analogs (NAs) |
| Nucleoside (acid) analogs (NAs)Inhibit viral replication. | Drug | 0.2mg quaque die (QD) placebo, combined with nucleoside (acid) analogs (NAs), Placebo 0.5mg once the next day (QOD) , combined with nucleoside (acid) analogs (NAs), Placebo 0.5mg quaque die (QD) combined with nucleoside (acid) analogs (NAs), TQ-A3334 tablets 0.2mg quaque die (QD), combined with nucleoside (acid) analogs (NAs), TQ-A3334 tablets 0.5mg once the next day(QOD), combined with nucleoside (acid) analogs (NAs), TQ-A3334 tablets 0.5mg quaque die (QD), combined with nucleoside (acid) analogs (NAs) |
Primary outcome
At 24 weeks, the changes in serum HBSAG relative to the baseline
Time frame: Up to 24 weeks
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
18 secondary outcomes
The incidence of adverse events（AEs）
Time frame: Up to 48 weeks
Severity of adverse events (AEs)
Time frame: Up to 48 weeks
Incidence of serious adverse events (SAEs)
Time frame: Up to 48 weeks
Severity of serious adverse events（SAEs）
Time frame: Up to 28 weeks
HBsAg<100 IU/ml and HBV DNA <20 IU/ml subject
Time frame: Week 24, 48 weeks, 60 weeks, 72 weeks
HBSAG self -based lines drop ≥0.5, ≥1 Log10IU/ml
Time frame: Week 24, 48 weeks, 60 weeks, 72 weeks
The proportion of subjects of HBSAG serological removal and/or serum transformation during the study period
Time frame: Week 24, 48 weeks, 60 weeks, 72 weeks
The proportion of subjects of HBEAG serological removal and/or serum conversion during the study period
Time frame: Week 24, 48 weeks, 60 weeks, 72 weeks
Peak time (Tmax)
Time frame: Day1 0 hour pre-dose,10,20,30minutes,1,2,3,6,12,24,48 hours after dose, Day15 within 60 minutes pre-dose, Day29 0h pre-dose,10, 20, 30 minutes, 1,2,3,6,12,24,48 hours after dose, Day57 and Day85 0hour pre-dose
Peak Concentration
Time frame: Day1 0 hour pre-dose,10,20,30minutes,1,2,3,6,12,24,48 hours after dose, Day15 within 60 minutes pre-dose, Day29 0h pre-dose,10, 20, 30 minutes, 1,2,3,6,12,24,48 hours after dose, Day57 and Day85 0hour pre-dose
Area under blood concentration-time curve (AUC)
Time frame: Day1 0 hour pre-dose,10,20,30minutes,1,2,3,6,12,24,48 hours after dose, Day15 within 60 minutes pre-dose, Day29 0h pre-dose,10, 20, 30 minutes, 1,2,3,6,12,24,48 hours after dose, Day57 and Day85 0hour pre-dose
Apparent volume of distribution (Vd/F)
Time frame: Day1 0 hour pre-dose,10,20,30minutes,1,2,3,6,12,24,48 hours after dose, Day15 within 60 minutes pre-dose, Day29 0h pre-dose,10, 20, 30 minutes, 1,2,3,6,12,24,48 hours after dose, Day57 and Day85 0hour pre-dose
Plasma clearance
Time frame: Day1 0 hour pre-dose,10,20,30minutes,1,2,3,6,12,24,48 hours after dose, D15 within 60 minutes pre-dose, Day29 0h pre-dose,10, 20, 30 minutes, 1,2,3,6,12,24,48 hours after dose, D57 and D85 0hour pre-dose.
Elimination half-life time
Time frame: Day1 0 hour pre-dose,10,20,30minutes,1,2,3,6,12,24,48 hours after dose, Day15 within 60 minutes pre-dose, Day29 0h pre-dose,10, 20, 30 minutes, 1,2,3,6,12,24,48 hours after dose, Day57 and Day85 0hour pre-dose
Peaking Time
Time frame: Day1 0 hour pre-dose,10,20,30minutes,1,2,3,6,12,24,48 hours after dose, D15 within 60 minutes pre-dose, Day29 0h pre-dose,10, 20, 30 minutes, 1,2,3,6,12,24,48 hours after dose, D57 and D85 0hour pre-dose.
Steady state maximum concentration
Time frame: Day1 0 hour pre-dose,10,20,30minutes,1,2,3,6,12,24,48 hours after dose, Day15 within 60 minutes pre-dose, Day29 0h pre-dose,10, 20, 30 minutes, 1,2,3,6,12,24,48 hours after dose, Day57 and Day85 0hour pre-dose
Steady state minimal concentration
Time frame: Day1 0 hour pre-dose,10,20,30minutes,1,2,3,6,12,24,48 hours after dose, Day15 within 60 minutes pre-dose, Day29 0h pre-dose,10, 20, 30 minutes, 1,2,3,6,12,24,48 hours after dose, Day57 and Day85 0hour pre-dose
Area under steady-state blood concentration-time curve
Time frame: Day1 0 hour pre-dose,10,20,30minutes,1,2,3,6,12,24,48 hours after dose, Day15 within 60 minutes pre-dose, Day29 0h pre-dose,10, 20, 30 minutes, 1,2,3,6,12,24,48 hours after dose, Day57 and Day85 0hour pre-dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
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Hepatitis D, Hepatitis C
RecruitingPhase 2
A Study to Evaluate the Efficacy and Safety of Combination Therapy of BRII-179, BRII-835 and PEG-IFNα in Participants With Chronic Hepatitis B Virus (HBV) Infection (ENHANCE)
Chronic Hepatitis B Virus (HBV) Infection
RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer
Not yet recruitingPhase 1
A Clinical Study of AHB-121 in Healthy Participants and Chronic Hepatitis B (CHB) Participants
Chronic Hepatitis B Virus
Not yet recruitingPhase 1/2
A Study of Sequential Therapy With AHB-137 Injection Followed by TVAX-008 Injection in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TQA3334 Tablet and Nucleoside (acid) analogs (NAs) in people with Chronic Hepatitis B, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 15 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 12 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: under way, not looking for participants, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
At 24 weeks, the changes in serum HBSAG relative to the baseline (time frame: Up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Sep 2026.