A Clinical Trial to Evaluate the Efficacy and Safety of TQA3810 Tablets in Combination/Non Combination With Nucleoside (Acid) Analogues in Patients With Primary/Treated Chronic Hepatitis B
- Conditions
- Chronic Hepatitis B
- Registration Number
- NCT06566248
- Lead Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 90
Inclusion Criteria:<br><br> - Age 18-70 (including boundary values), male or female.<br><br> - Serum virological criteria: serum HBsAg positive for more than 6 months or evidence<br> of chronic hepatitis B for more than 6 months. During the screening period, 100<br> IU/ml=HBsAg quantification =10000 IU/ml.<br><br> - No obvious cirrhosis was found by the researchers.<br><br> - The subjects can communicate well with the researchers, understand and comply with<br> the requirements of this study, and understand and sign the informed consent.<br><br> - The 12-lead electrocardiogram was normal, or there were no clinically significant<br> abnormal values as assessed by the investigator.<br><br>Treated patients must meet the following conditions:<br><br> - Subjects must have received oral nucleoside (acid) therapy (entecavir/ Tenofovir<br> alafenamide Fumarate tablets/Tenofovir Disoproxil Fumarate Tablets) for =6 months<br> prior to screening and stable treatment regimen for =3 months prior to screening.<br><br> - Patients with medical history 6 months or more before enrollment had HBV DNA< the<br> lower limit of normal detection, and hepatitis B virus (HBV) DNA<20 IU/mL was<br> detected by Roche COBAS Taqman during the screening period.<br><br>Newly treated patients need to meet the following conditions:<br><br> - At the time of screening, subjects had never received antiviral treatment for<br> chronic hepatitis B (oral nucleoside drugs and interferon), or had received<br> irregular antiviral treatment in the past, and had not received any antiviral<br> treatment for chronic hepatitis B in the first 3 months of enrollment.<br><br> - HBV DNA=2000 IU/mL(Roche COBAS Taqman).<br><br>Exclusion Criteria:<br><br> - Combined with other viral infections such as hepatitis A virus,hepatitis C virus,<br> hepatitis D virus, hepatitis E virus, human immunodeficiency virus,syphilis<br> (syphilis antibody positive by the researchers to determine the need for treatment).<br> If hepatitis C virus (HCV) antibody positive, HCV RNA negative can not be excluded.<br><br> - Patients with significant fibrosis or cirrhosis before or at the time of screening:<br> liver histopathological findings indicating Metavir F3 or F4 within 1 year before<br> screening; FibroScan= 9.7 kPa 6 months before screening in treated patients and =<br> 12.4 kPa 6 months before screening in newly treated patients; Abdominal<br> ultrasonography suggested suspected cirrhosis. Previous history of hepatic<br> decompensation or screening period of hepatic decompensation, such as ascites,<br> hepatic encephalopathy, esophageal and gastric varices bleeding, etc.<br><br> - Patients with a history of hepatocellular carcinoma (HCC) before or at the time of<br> screening, or who may be at risk for HCC, such as suspicious nodules on imaging, or<br> abnormal AFP (AFP>50ng/mL), should be excluded from HCC before enlisting.<br><br> - A history of malignant tumors within 5 years prior to screening, except for certain<br> cancers that can be completely cured by surgical resection (such as skin basal cell<br> carcinoma). Subjects being evaluated for active or suspected malignancy at the time<br> of screening.<br><br> - Patients with other chronic liver diseases, including but not limited to autoimmune<br> liver disease, alcoholic liver disease, hepatolenticular degeneration, etc.<br><br> - Have previously received organ transplantation and bone marrow transplantation.<br><br> - Patients with uncontrolled thyroid disease.<br><br> - Eye diseases: including fundus lesions (cotton wool changes in the fundus with<br> symptoms) and retinopathy.<br><br> - Autoimmune diseases include but are not limited to: systemic lupus erythematosus,<br> rheumatoid arthritis, inflammatory bowel disease, sarcoidosis, psoriasis, autoimmune<br> uveitis, etc.<br><br> - Current alcohol and drug abuse was determined by the investigator. Subjects with a<br> history of excessive alcohol use. A history of excessive alcohol use was defined as<br> alcohol consumption >210g per week for men and >140g for women in the past 12<br> months. Alcohol intake (g) = amount of alcohol consumed (ml) × alcohol degree % ×<br> 0.8.<br><br> - Blood transfusion =2 months before screening and/or blood donation =1 month before<br> screening. Note: Subjects were not allowed to donate blood throughout the study<br> period.<br><br> - Have a history of allergy to the experimental drug or its excipients;<br><br> - Female subjects are pregnant, breastfeeding or have positive pregnancy results<br> during the screening period or during the test;<br><br> - Those that researchers believe should not be included.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) during the study period
- Secondary Outcome Measures
Name Time Method Changes in serum HBsAg;HBV DNA level changes and drug resistance monitoring;HBeAg level change;HBsAg clearance and/or serological conversion;HBeAg clearance and/or serological conversion;HBsAg level decreased by =0.5log10 IU/ml;Changes of HBV RNA and hepatitis B core-related antigen (HBcrAg) levels during treatment;Peak time (Tmax);Peak Concentration;Area under blood concentration-time curve (AUC);Apparent volume of distribution (Vd/F);Plasma clearance;Elimination half-life time;Peaking Time;Steady state maximum concentration;Steady state minimal concentration;Area under steady-state blood concentration-time curve;Evaluate whether TQA3810 will affect the heart rate-corrected QT interval (QTc) of newly treated/treated chronic hepatitis B patients;Pharmacodynamic characteristics (IFN-?, IL-1RA, CCL2, CCL4, CCL8, CCL11, CCL20, CXCL8, IL-12p70, IL-12p40, TNF-a, CRP)