CHB with poor response to antiviral therapy for hepatitis B
Conditions
Interventions
Experimental group:Experimental Group (GST-HG141 + NAs): GST-HG141 50 mg (2 tablets) BID, administered orally after meals, for 48 weeks of treatment
plus NAs monotherap
Control group:Placebo Group (GST-HG141 Placebo + NAs): GST-HG141 placebo (2 tablets) BID, administered orally after meals, for 48 weeks of treatment
Sponsors
Shulan (Hangzhou) Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Male or female aged 18-70 years (inclusive of the boundary values). 2. Male subjects with a body weight of >= 50 kg, female subjects with a body weight of >= 45 kg, and a body mass index (BMI) within the range of 18-35 kg/m^2(inclusive of the boundary values). 3. Having continuously received monotherapy or combination therapy with nucleoside analogues (entecavir [ETV], tenofovir disoproxil fumarate [TDF], alafenamide tenofovir [TMF], or tenofovir alafenamide [TAF]) for more than 1 year (with an interruption time of less than 1 month in the recent year), and being on treatment at the time of screening and agreeing to receive the treatment regimen provided in this study during the study period. 4. HBeAg positive, with serum HBV DNA detectable by high-sensitivity PCR, and HBV DNA > 50 IU/mL. 5. At the time of screening, ALT <= 5×ULN. 6. Male subjects whose female partners are of childbearing potential, or female subjects of childbearing age, voluntarily adopt effective contraceptive measures from screening until 28 days after withdrawal from the study. 7. Signed the informed consent form before the trial and is able to complete the study in accordance with the requirements of the trial protocol.
Exclusion criteria
Exclusion criteria: 1.Subjects with a history of life-threatening severe allergic reactions such as anaphylactic shock, or those suspected by the investigator to be allergic to the active ingredients of the study drug or its excipients. 2.Having combined use of inhibitors, inducers, or substrates of cytochrome P450 enzyme 3A4 (CYP3A4) within 28 days before screening. 3.Subjects who have systemically used immunosuppressants, immunomodulators (interferon requires discontinuation for more than 12 months) and cytotoxic drugs within 6 months before screening; or subjects who have received live attenuated vaccines within 1 month before screening. 4.Subjects with acute infections requiring treatment before randomization. 5.Having clinically significant acute or chronic liver diseases not caused by HBV infection. 6.Subjects with a history of cirrhosis (e.g., subjects who have undergone liver histopathological examination with a report indicating cirrhosis, or have undergone endoscopy suggesting esophagogastric varices, or have a liver stiffness measurement [LSM] value = 10.6 kPa in liver elastography during screening); or subjects currently diagnosed or suspected of having decompensated cirrhosis, including but not limited to: hepatic encephalopathy, hepatorenal syndrome, esophagogastric variceal bleeding, splenomegaly, ascites, etc.; or subjects with significant progression of liver fibrosis. 7. Primary liver cancer; serum alpha-fetoprotein (AFP) greater than 20 µg/L (or 20 ng/mL) or abnormal prothrombin (DCP) greater than 40 mAU/mL or imaging suggesting a malignant liver mass; coexisting with other malignant tumors (excluding cured skin basal cell or squamous cell carcinoma, and cervical carcinoma in situ); 8.Subjects with impaired gastrointestinal function or gastrointestinal diseases that may affect the absorption of oral drugs as judged by the investigator, such as severe gastrointestinal diseases (peptic ulcer, erosive or atrophic gastritis), partial gastrectomy, or grade > 2 gastrointestinal symptoms (e.g., nausea, vomiting, or diarrhea) at screening. 9.Subjects with severe diseases of the circulatory, respiratory, urinary, hematological, metabolic, immune, mental, neurological, renal or other systems, which are judged by the investigator as unsuitable for participation in this study. 10.Subjects who have had major trauma or undergone major surgery within 3 months before screening; or plan to undergo surgery during the study period. 11. Laboratory tests: a) Platelet count 2×ULN; e) Albumin 1.5; 12.Subjects with positive anti - HCV antibody, positive HIV antigen/antibody, positive Treponema pallidum antibody and positive Rapid Plasma Reagin (RPR) test. 13.Having a history of continuous alcohol abuse within 3 years before screening (weekly alcohol consumption > 14 alcohol units; 1 alcohol unit is defined as 350ml of beer, 120ml of wine, or 30ml of spirits with 40% alcohol content). 14.Having a history of drug dependence or drug abuse. 15.Subjects who participated in clinical trials of other investigational drugs or medical devices, and took the trial drugs or used the medical devices within 3 months before screening. 16.Lactating women or those with a positi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HBV DNA quantification; | — |
Secondary
| Measure | Time frame |
|---|---|
| HBV DNA quantification;HBeAg seroconversion negative;Serum HBV pgRNA;HBV DNA quantification;HBV DNA quantification; | — |
Countries
China
Contacts
Public ContactLi Lanjuan
Shulan (Hangzhou) Hospital
Outcome results
None listed