Chronic hepatitis B
Conditions
Interventions
Tenofovir alafenamide Fumarate tablets (TAF) treatment group:TAF
Tenofovir Amibufenamide (TMF) treatment group:TMF
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.The age is between 18 and 65 years old, and there is no gender limit for men and women; 2.Have a clear history of chronic hepatitis B, and the course of disease is more than 6 months; 3.HBeAg negative, with or without anti HBE positive; 4.The treated patients were treated with entecavir or propofol tenofovir, and the serum HBV DNA was lower than the lower limit of detection, and maintained stable treatment for at least 6 months before screening; 5.The newly treated patients had no history of antiviral treatment; 6.Child - Pugh liver function classification was a grade; 7.The diagnosis was nodular cirrhosis, with two or more of the following imaging examinations: liver ultrasound showed that the liver surface was not smooth, with nodular changes, the echo of liver parenchyma was thickened, enhanced and unevenly distributed, and the vascular texture was disordered; CT examination showed that the liver volume was reduced, the proportion of liver lobes was imbalanced, the liver fissure was widened, the liver surface was uneven, and multiple nodules of different sizes could be seen; MRI examination showed abnormal liver morphology, uneven signal of liver parenchyma, slightly hypointense or isointense on T1WI, slightly hyperintense on T2WI, and nodules on enhanced scan could have different degrees of enhancement. 8.Voluntarily participated in this study and signed the informed consent.
Exclusion criteria
Exclusion criteria: 1.Combined with other viral hepatitis (such as hepatitis A, C, D, E virus infection), autoimmune liver disease and alcoholic liver disease (there is a history of heavy drinking in recent 1 year, the daily alcohol consumption of men is more than 40 g, and that of women is more than 20 g), drug-induced liver disease (there is a clear history of taking drugs for liver injury recently). 2.There are serious heart, lung, kidney and other important organ dysfunction, such as severe heart failure (NYHA class III-IV), severe chronic obstructive pulmonary disease (fev1/fvc < 50% predicted value with respiratory failure and other serious complications), chronic renal insufficiency (estimated glomerular filtration rate EGFR < 30 ml/min/1.73m ²). 3.Have a history of liver cancer or other malignant tumors. 4.Mental illness is present. 5. Pregnant or lactating women 6. Allergic to the study drug or its excipients 7.Have received clinical trials of other antiviral drugs or used immunomodulators, cytotoxic drugs and other drugs that may affect liver function or immune status within 3 months before screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Hepatocellular Carcinoma;Changes in Liver Cirrhosis;Incidence of Decompensated Liver Cirrhosis;Undetectable Rate of HBV RNA;Undetectable Rate of HBV DNA;Decline in Serum HBsAg Levels;HBsAg Seroclearance;5-Year Survival Outcomes;Cost-Effectiveness of Treatment; | — |
Countries
China
Contacts
Public ContactEnqiang Chen
West China Hospital, Sichuan University
Outcome results
None listed