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

CTTQ

Status and phase: Active, not recruiting; Phase 2

Conditions: Chronic Hepatitis B

Treatments: Drug: Placebo; Drug: Nucleoside (acid) analogs (NAs); Drug: TQA3334 Tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT06706310

TQ-A3334-II-03

Details and patient eligibility

About

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.

Enrollment: 116 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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116 participants in 6 patient groups, including a placebo group

TQ-A3334 tablets 0.2mg quaque die (QD), combined with nucleoside (acid) analogs (NAs)

Active Comparator group

Description:

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.

Treatment:

Drug: TQA3334 Tablet

Drug: Nucleoside (acid) analogs (NAs)

0.2mg quaque die (QD) placebo, combined with nucleoside (acid) analogs (NAs)

Placebo Comparator group

Description:

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.

Treatment:

Drug: Nucleoside (acid) analogs (NAs)

Drug: Placebo

TQ-A3334 tablets 0.5mg once the next day(QOD), combined with nucleoside (acid) analogs (NAs)

Active Comparator group

Description:

TQA333 tablets 0.5mg once the next day once the next day, administration for 48 weeks; combined medication 1/day, 72 weeks of administration.

Treatment:

Drug: TQA3334 Tablet

Drug: Nucleoside (acid) analogs (NAs)

Placebo 0.5mg once the next day (QOD) , combined with nucleoside (acid) analogs (NAs)

Placebo Comparator group

Description:

Placebo 0.5mg once the next day, administration for 48 weeks; combined medication 1/day, 72 weeks of administration;

Treatment:

Drug: Nucleoside (acid) analogs (NAs)

Drug: Placebo

TQ-A3334 tablets 0.5mg quaque die (QD), combined with nucleoside (acid) analogs (NAs)

Active Comparator group

Description:

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.

Treatment:

Drug: TQA3334 Tablet

Drug: Nucleoside (acid) analogs (NAs)

Placebo 0.5mg quaque die (QD) combined with nucleoside (acid) analogs (NAs)

Placebo Comparator group

Description:

Placebo 0.5mg once a day, 1/night, 48 weeks of administration; 1 time/day for combined medication, 72 weeks of administration; 72 weeks.

Treatment:

Drug: Nucleoside (acid) analogs (NAs)

Drug: Placebo