Chronic Hepatitis B
Conditions
Interventions
Other NAs Group:None
Oral Pradefovir Mesylate Tablets Group:None
Sponsors
Xixi Hospital of Hangzhou
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 65 years (inclusive), regardless of gender; 2. Meeting the diagnostic criteria for chronic hepatitis B (documented HBsAg or HBV DNA positivity for more than 6 months, or confirmed by liver biopsy); 3. Meeting the indications for antiviral therapy as per the Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2022 edition): (1) Serum HBV DNA positivity with persistently abnormal ALT (> ULN) after excluding other causes; (2) Serum HBV DNA positivity, regardless of ALT level, if any of the following conditions is met: ?. Family history of hepatitis B-related cirrhosis or hepatocellular carcinoma (HCC); ?. Age > 30 years; ?. Non-invasive indicators or histologic evidence suggesting significant liver inflammation (G >= 2) or fibrosis (F >= 2); ?. HBV-related extrahepatic manifestations (e.g., HBV-associated glomerulonephritis); (3) Clinically diagnosed compensated hepatitis B-related cirrhosis; Patients currently or imminently receiving nucleos(t)ide analog (NAs) oral antiviral therapy; experienced patients must have received NAs for >= 48 weeks; 4. Baseline HBsAg > 1500 IU/mL; 5. No history of interferon therapy within the past 6 months; 6. Awareness of the study content and voluntary participation.
Exclusion criteria
Exclusion criteria: 1.Evidence suggestive of hepatocellular carcinoma or serum alpha-fetoprotein (AFP) > 100 µg/L; 2.Signs of significant hepatic decompensation, such as ascites, hepatic encephalopathy, or esophagogastric variceal bleeding; 3.Platelet count (PLT) 2.5 × upper limit of normal (ULN); 4.Coinfection with hepatitis C or D virus, HIV, autoimmune hepatitis, or other causes of active hepatitis; 5.History of allergy to nucleosides or nucleoside analogs; 6.Severe cardiopulmonary dysfunction, advanced malignancy, central nervous system disorders (e.g., history of epilepsy), or other systemic diseases; 7.Neurological or psychiatric disorders rendering patients unable or unwilling to cooperate; 8.Pregnant or lactating women, or those with recent pregnancy plans; 9.Use within the past 3 months, or current use, of strong or weak inhibitors of CYP3A4 or P-gp (e.g., ketoconazole, erythromycin, itraconazole) or strong inducers of CYP3A4 or P-gp (e.g., rifampicin, phenytoin sodium); 10.Inability to consent or unlikely to complete the 48-week follow-up after enrollment; 11.Investigators’ judgment of unsuitability for clinical trial participation.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Liver function indicators;Incidence of adverse events;Safety Evaluation;Virological markers?;Liver fibrosis indices?; | — |
Primary
| Measure | Time frame |
|---|---|
| Proportion of the clinical cure-favorable population; | — |
Countries
China
Contacts
Public ContactLiu Shourong
Xixi Hospital of Hangzhou
Outcome results
None listed