Chronic HBV infection with low-level viremia
Conditions
Interventions
group1:TQA3605 Placebo+NAs
group2:100mgTQA3605 tablets+NAs
group3:200mgTQA3605 tablets+NAs
Sponsors
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. 18-65 years old (including boundary values), male or female; 2. Screening may provide etiological or clinical or pathological evidence of hepatitis B virus infection for more than 1 year; HBsAg positive, 20 IU/mL =6 months prior to screening; 4. Be able to communicate well with the researcher, understand and comply with the requirements of the study, understand and sign the informed consent; 5. Male subjects with fertile female partners or female subjects of childbearing age were willing to voluntarily take effective contraceptive measures within 3 months after screening.
Exclusion criteria
Exclusion criteria: 1. Pregnant (positive pregnancy test) or breastfeeding women; 2. Combined with other viral infections such as HAV, HCV, HDV, HEV, HIV, syphilis, etc; 3. History of cirrhosis or evidence of significant fibrosis or cirrhosis before/at screening; 4. Subjects had a history of hepatocellular carcinoma (HCC) or suspected HCC before or at screening; 5. Patients with a history of malignancy within the previous 5 years were screened, excluding certain cancers that were completely curable by surgical resection; 6. Subjects with other chronic liver diseases, including but not limited to autoimmune liver disease, alcoholic liver disease, and hepatolenticular degeneration; 7. Always has received organ transplantation and bone marrow transplantation; 8. There were abnormal laboratory examination indicators specified in the scheme during screening; 9. Poorly controlled thyroid disease, or clinically significant thyroid dysfunction; 10. Autoimmune disease; 11. In addition to liver disease, there are also obvious systemic or major diseases; 12. Received any systemic antitumor or immunosuppressive therapy or immunomodulatory therapy within 6 months prior to screening; 13. High doses of systemic corticosteroids were received within 3 months prior to the screening period; 14. History of alcohol and drug abuse within 1 year prior to screening period; 15. Blood transfusion <=2 months before screening and/or blood donation <=1 month before screening; 16. History of allergy to the investigational drug or its excipients; 17. Previously participated in clinical trials of hepatitis B core protein allosteric regulators; 18. Subjects have participated in a clinical trial and received the investigational drug during the following time period prior to the first administration of the study: 5 half-lives or twice the duration of the biological effects of the study treatment or 90 days; 19. History or condition of cardiovascular disease; 20. Who the researchers believe should not be included;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HBV DNA; | — |
Secondary
| Measure | Time frame |
|---|---|
| The incidence and severity of adverse events (AEs) and serious adverse events (SAEs) during the study period;Percentage of subjects with a virological breakthrough;Steady state peak concentration (Cmax, ss), steady state valley concentration (Cmin, ss);Percentage of subjects with HBV DNA < 10 IU/mL;ALT recovery rate;The percentage of subjects with HBeAg serological clearance and/or serological conversion (only for those with HBeAg positive at baseline);51/5000 Actual values of HBsAg, HBeAg, HBV DNA, HBV RNA, and HBcrAg and changes over time relative to baseline;Percentage of subjects with HBV DNA < 20 IU/mL; | — |
Countries
China
Contacts
Public ContactXie Qing
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed