Evaluate TQ-A3334 Combined Nucleoside (Acid) Analogs in the First Treatment/Treatment of Chronic HBV Infection

Phase 2

Recruiting

• Conditions: Chronic Hepatitis B
• Interventions: Drug: TQA3334 Tablet; Drug: Placebo; Drug: Nucleoside (acid) analogs (NAs)

• Registration Number: NCT06706310
• Lead Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-11-20
• Study First Submitted QC: 2024-11-22
• Study First Posted: 2024-11-26
• Study Start: 2024-12-04
• Last Update Submitted: 2025-02-28
• Last Update Posted: 2025-03-04
• Primary Completion: 2025-12
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 116

Inclusion Criteria

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:

• 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)

Exclusion Criteria

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;
• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TQ-A3334 tablets 0.2mg quaque die (QD), combined with nucleoside (acid) analogs (NAs)	TQA3334 Tablet	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.
TQ-A3334 tablets 0.2mg quaque die (QD), combined with nucleoside (acid) analogs (NAs)	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	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.
0.2mg quaque die (QD) placebo, combined with nucleoside (acid) analogs (NAs)	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)	TQA3334 Tablet	TQA333 tablets 0.5mg once the next day once the next day, administration for 48 weeks; combined medication 1/day, 72 weeks of administration.
TQ-A3334 tablets 0.5mg once the next day(QOD), combined with nucleoside (acid) analogs (NAs)	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	Placebo 0.5mg 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)	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)	TQA3334 Tablet	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.
TQ-A3334 tablets 0.5mg quaque die (QD), combined with nucleoside (acid) analogs (NAs)	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	Placebo 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)	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.

Primary Outcome Measures

Name	Time	Method
At 24 weeks, the changes in serum HBSAG relative to the baseline	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

Secondary Outcome Measures

Name	Time	Method
The incidence of adverse events（AEs）	Up to 48 weeks	To investigate the incidence of adverse events (AEs) during treatment
Severity of adverse events (AEs)	Up to 48 weeks	To study the severity of adverse events (AEs) during treatment
Incidence of serious adverse events (SAEs)	Up to 48 weeks	To investigate the incidence of serious adverse events (SAEs) during treatment
Severity of serious adverse events（SAEs）	Up to 28 weeks	To investigate the severity of serious adverse events (SAEs) during treatment
HBsAg<100 IU/ml and HBV DNA <20 IU/ml subject	Week 24, 48 weeks, 60 weeks, 72 weeks	The proportion of subjects of HBsAg\<100 IU/ml and HBV DNA \<20 IU/ml.
HBSAG self -based lines drop ≥0.5, ≥1 Log10IU/ml	Week 24, 48 weeks, 60 weeks, 72 weeks	Awarded by HBSAG's self -base line decrease ≥0.5, ≥1 Log10IU/ml.
The proportion of subjects of HBSAG serological removal and/or serum transformation during the study period	Week 24, 48 weeks, 60 weeks, 72 weeks	HBSAG serum science clearance and/or serum transition ratio proportion
The proportion of subjects of HBEAG serological removal and/or serum conversion during the study period	Week 24, 48 weeks, 60 weeks, 72 weeks	The proportion of subjects of HBEAG serological removal and/or serum transformation during the study.
Peak time (Tmax)	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	Time to peak blood concentration after a single dose.
Peak Concentration	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	The highest plasma drug concentration that can be achieved after medication.
Area under blood concentration-time curve (AUC)	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	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.
Apparent volume of distribution (Vd/F)	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	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
Plasma clearance	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.	How many milliliters of plasma can the kidneys completely clear in unit time (per minute)
Elimination half-life time	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	The time it takes for the plasma concentration to drop by half.
Peaking Time	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.	The time required to reach peak steady-state concentration after administration.
Steady state maximum concentration	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	The highest blood concentration that occurs after stabilization.
Steady state minimal concentration	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	The lowest blood concentration that occurs after stabilization
Area under steady-state blood concentration-time curve	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	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.

Trial Locations

Locations (15)

The First Affiliated Hospital of Chongqing Medical University; 🇨🇳 Chongqing, Chongqing, China

The Third Affiliated Hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China

Peking University Shenzhen Hospital; 🇨🇳 Shenzhen, Guangdong, China

Hospital workers in Liuzhou; 🇨🇳 Liuzhou, Guangxi, China

WuHan Jinyintan Hospital; 🇨🇳 WuHan, Hubei, China

The Second XIANGYA Hospital Of Central South University; 🇨🇳 Changsha, Hunan, China

The Fifth People's Hospital of Wuxi (Affiliated Wuxi Fifth Hospital of Jiangnan University); 🇨🇳 Wuxi, Jiangsu, China

The first hospital of Jilin University; 🇨🇳 Changchun, Jilin, China

The Sixth People's Hospital of Shenyang; 🇨🇳 Shenyang, Liaoning, China

The First Affiliated Hospital of Xi'an Jiao Tong University; 🇨🇳 Xi'an, Shaanxi, China

West China Hospital of Sichuan University; 🇨🇳 Chengdu, Sichuan, China

The First Affiliated Hospital of Xinjiang Medical University; 🇨🇳 Ürümqi, Xinjiang, China

First People's Hospital of Yunnan Province; 🇨🇳 Kunming, Yunnan, China

Pu'er People's Hospital; 🇨🇳 Pu'er, Yunnan, China

People's Hospital Of RuiAn City; 🇨🇳 Rui'an, Zhejiang, China