This is a multicenter, randomized, double-blind, placebo-controlled Phase III study with an open-label extension. The purpose is to evaluate efficacy and safety in adult patients with chronic hepatitis B virus infection who have received at least 12 months of NAs therapy, to demonstrate that TQA3605 Tablets combined with oral nucleos(t)ide analogues can improve efficacy with satisfactory safety profile compared with oral nucleos(t)ide analogues alone in this population. Approximately 930 adult patients with chronic hepatitis B virus infection who have received at least 12 months of NAs therapy are planned to be enrolled in this study.
Male or female participants aged 18-65 years (inclusive) at screening.
Able to communicate effectively with the investigator, understand and comply with all requirements of this study, and understand and sign the informed consent form.
Have received continuous treatment with nucleos(t)ide analogues (entecavir, tenofovir disoproxil fumarate, tenofovir alafenamide fumarate or tenofovir amibufenamide) or NAs combination therapy for ≥ 12 months at screening, with a stable single regimen for ≥ 6 months (medication adherence > 90% in the past 12 months, with no treatment interruption exceeding 15 consecutive days).
Etiological evidence is available at screening to confirm chronic HBV infection of more than 1 year (HBsAg positive and/or HBV DNA positive for at least 1 year).
Pregnant women (positive pregnancy test) or breastfeeding women.
Co-infection with other viruses such as HAV, HCV, HDV, HEV, HIV, or syphilis (participants with positive syphilis antibody who require treatment as judged by the investigator; Participants with positive HCV antibody and negative HCV RNA may not be excluded).
History of liver cirrhosis; or liver histopathology obtained within 1 year prior to screening indicating Metavir ≥ S3, Scheuer ≥ S3 or Ishak ≥ S4; or FibroScan result ≥ 9.0 kPa within 6 months prior to screening; or previous endoscopy revealing esophageal and gastric varices; or suspected liver cirrhosis identified on abdominal ultrasonography at screening, such as ascites, hepatic encephalopathy, and bleeding from esophageal and gastric varices.
History of hepatocellular carcinoma (HCC) or suspected HCC at or prior to screening (e.g., suspicious lesions on imaging, or AFP ≥ 50 ng/mL).
Parallel
TQA3605 tablets Placebo
DrugPlacebo contains no active substance.
TQA3605 tablets
DrugTQA3605 tablets are core protein allosteric modulators
Entecavir dispersible tablets
DrugEntecavir dispersible tablets are a type of nucleoside analog antiviral drug.
Tenofovir Disoproxil Fumarate Tablets
DrugTenofovir Disoproxil Fumarate (TDF) is a nucleoside reverse transcriptase inhibitor.
Tenofovir Alafenamide Fumarate Tablets
DrugTenofovir Alafenamide Fumarate (TAF) is a nucleoside reverse transcriptase inhibitor.
Tenofovir Amibufenamide Tablets
DrugTenofovir Amibufenamide (TMF) is a phosphoramidate prodrug of tenofovir and belongs to nucleos(t)ide reverse transcriptase inhibitors.
HBV DNA
Difference in the percentage of trial participants achieving HBV DNA less than 10 IU/mL after 48 weeks of treatment between the treatment group and the control group
HBV DNA
Percentage of trial participants with HBV DNA less than 10 IU/mL at each visit (excluding Week 48)
HBV DNA
Percentage of trial participants with HBV DNA less than 20 IU/mL at each visit
HBsAg
Percentage of trial participants with HBsAg less than 0.05 IU/mL;
HBeAg
Percentage of trial participants achieving HBeAg seroclearance and/or seroconversion
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
