Chronic hepatitis B
Conditions
Interventions
Antiviral treatment alone group:None
Antiviral therapy combined with Compound Biejia Ruangan Tablets group:None
Sponsors
The Second Hospital of Nanjing
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed with advanced liver fibrosis or compensated cirrhosis due to chronic hepatitis B, according to "Guidelines for Prevention and Treatment of Chronic Hepatitis B (2022 Edition)", "Consensus on Diagnosis and Treatment of Liver Fibrosis (2019 Edition)", and "Guidelines for Diagnosis and Treatment of Liver Cirrhosis (2019 Edition)". 2. Ages between 18-65 years old (over 18, under or equal to 65), regardless of gender. 3. Laboratory tests: INR = 1.5; PLT = 50×109/L; ALT = 3×ULN; TBiL = 3×ULN; AFP = 1×ULN. 4. Including treatment-naive patients who have not taken antiviral drugs within 1 year or anti-fibrotic drugs within 6 months, and treated patients currently receiving first-line nucleos(t)ide analog antiviral therapy combined with or without anti-fibrotic treatment, including Compound Biejia Ruangan Tablets. 5. Signed an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Decompensated cirrhosis patients (including those with a history of decompensated cirrhosis), defined as: i: Meeting the diagnostic criteria for cirrhosis. ii: Presenting with decompensating complications such as ascites, esophagogastric variceal bleeding, hepatic encephalopathy, etc. 2. Laboratory tests: INR > 1.5; PLT 3×ULN; TBiL > 3×ULN; AFP > 1×ULN; eGFR 1.5×ULN. 3. Patients with primary liver cancer. 4. Pregnant or lactating women, or women of childbearing age planning pregnancy within two years. 5. Patients with an allergic predisposition or allergies to the Chinese herbal medicines used. 6. Patients with uncontrolled severe primary diseases of the heart, kidney, lung, endocrine system, blood, metabolism, or gastrointestinal tract, or psychiatric disorders. 7. Patients co-infected with HIV, tuberculosis, or other hepatitis virus infections (e.g., HCV, HDV). 8. Patients with chronic liver diseases such as hepatolenticular degeneration, autoimmune liver diseases, alcoholic liver diseases (except fatty liver). 9. Patients deemed unsuitable for this study by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 5-year cumulative incidence of hepatocellular carcinoma;5-year cumulative incidence of decompensated cirrhosis;5-year cumulative liver-related mortality rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in levels and abnormal proportions of AFP compared to baseline.;Changes in liver stiffness compared to baseline;Changes in aMAP score compared to baseline;Changes in FIB-4 score compared to baseline;Changes in liver function compared to baseline;Changes in virological parameters compared to baseline; | — |
Countries
China
Contacts
Public ContactYang Yongfeng
The Second Hospital of Nanjing
Outcome results
None listed