Compensated cirrhosis due to chronic hepatitis B
Conditions
Interventions
The group of NAs alone:NAs are taken orally once a day from week 1 to week 72
The group of NAs combined with IFN:For the PEG IFNa - 2b injection, it is administered once a week. The dosage is 90 µg from week 1 to week 12, and then 180 µg from week 13 to week 48. For NAs , they
Sponsors
Sichuan Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) Age: 18 - 70 years old (including 18 and 70 years old); (2) Gender: Both male and female are acceptable; (3) Hepatitis B diagnosis: HBsAg was previously positive for at least 6 months or other evidence indicates a history of chronic hepatitis B; (4) Liver fibrosis grading: The Ishak score of liver fibrosis is 2 - 5 points (including 2 and 5 points); (5) Cirrhosis diagnosis: Pathologically diagnosed as compensated post-hepatitis B cirrhosis; (6) Treatment history: The patient has been continuously treated with nucleoside (nucleotide) analogues for at least 12 weeks at the time of screening; (7) Informed consent: The patient voluntarily participate in this study, be able to understand and sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Patients with a history of decompensated cirrhosis in the past, or those currently with evidence of decompensated liver function, or those presenting with severe complications such as hepatic encephalopathy, ascites, pleural effusion, etc.; (2) Patients with liver malignant masses indicated by imaging examinations or those with other malignancies; (3) Patients with concurrent active viral infections such as hepatitis A, hepatitis C, hepatitis D, hepatitis E, HIV, etc.; (4) Patients with chronic liver diseases caused by other reasons, such as alcoholic hepatitis, drug-induced hepatitis, autoimmune liver diseases; (5) Patients with a history of autoimmune diseases, including psoriasis, systemic lupus erythematosus, etc.; (6) Patients with endocrine system diseases that are difficult to control with medications, including hyperthyroidism, hypothyroidism, diabetes, etc.; (7) Patients with concurrent kidney diseases: acute and chronic nephritis, renal insufficiency, nephrotic syndrome, etc.; (8) Patients with a history of severe heart diseases, or those with a New York Heart Association (NYHA) cardiac function classification of >= 3; (9) Patients with organic lesions or dysfunction of other important organs; (10) Patients with neurological or mental diseases, especially those with a history of mental diseases such as depression, anxiety, mania, schizophrenia, etc.; (11) Patients who have received anti-fibrotic drug treatment within 3 months before screening, including glycyrrhizin preparations, Fuzheng Huayu Capsules (Tablets), Anluo Huaxian Pills, Compound Biejia Ruangan Tablets, etc.; (12) Patients who have received antiviral drug treatment other than NAs within 3 months before screening, including interferon, ribavirin, sofosbuvir, etc.; (13) Patients who are planning to receive organ transplantation or have already undergone organ transplantation; (14) Prothrombin activity (PTA) 1:100; (17) Serum creatinine (Scr) > 1.5×ULN; (18) Patients who are allergic to interferon or drug excipients, or those who meet any of the contraindications stated in the instructions of the investigational drug; (19) Women of childbearing age with a positive pregnancy test within 24 hours before the first dose of the drug, or pregnant or lactating women, or patients with a fertility plan during the study period; (20) Patients who have participated in other interventional trials within 3 months before screening; (21) Other situations that the investigator deems unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Ishak score;Proportion of subjects with disease progression; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in the G grading of hepatic histopathological inflammation and S staging of fibrosis compared with the baseline;Proportion of subjects with a decrease of >= 1 point in the Ishak fibrosis score;Change in the FIB - 4 index of liver fibrosis compared with the baseline;Change in LSM (Liver Stiffness Measurement) compared to the baseline;HBV - DNA level, HBsAg level and HBsAg seroconversion rate;Liver function indicators; | — |
Countries
China
Contacts
Public ContactYuming Luo
Sichuan Provincial People's Hospital
Outcome results
None listed