hepatitis B
Conditions
Interventions
TDF monotherapy group:Tenofovir disoproxil fumarate
TAF monotherapy group:Tenofovir alafenamide fumarate
TDF combined LdT treatment group:Tenofovir disoproxil fumarate combined Telbivudine
TAF combined LdT treatment group:Tenofovir fumarate combined with Telbivudine
Sponsors
The Third Affiliated Hospital of Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years, gender is not limited; 2. Patients with chronic hepatitis B who meet the diagnostic criteria of the ''Guidelines for the Prevention and Treatment of Chronic Hepatitis B 2019 Edition''; 3. HBsAg positive >= 6 months, HBeAg positive; 4. Have not used NAs treatment; 5. Serum HBV DNA positive, persistent abnormal ALT (>ULN) and exclusion of other causes; 6. Serum HBV DNA positive, ALT normal but one of the following conditions: (1) Significant inflammation and (or) fibrosis in liver histology (G>=2 and (or) S>=2)]; (2) Have a family history of hepatitis B cirrhosis or hepatitis B liver cancer and the age is more than 30 years old; (3) For patients with ALT consistently normal and aged >30 years, non-invasive diagnostic techniques for liver fibrosis or liver histological examination are recommended, and there is obvious liver inflammation or fibrosis; (4) HBV-related extrahepatic manifestations (such as HBV-related glomerulonephritis, etc.); 7. Voluntarily participate in this research and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients who are pregnant or planning to become pregnant in the near future, and who are breastfeeding; 2. Participating in clinical investigators of other drugs; 3. Suspected liver cancer (AFP is elevated and B-ultrasound or CT indicates liver cancer); 4. Other causes of elevated ALT: such as infection with other pathogens, history of drug or poison use, history of alcohol use, fat metabolism disorder, autoimmune disorder, liver congestion or vascular disease, genetic metabolic liver injury, systemic system disease, etc.; 5. Patients with malignant tumor, HIV, and organ transplantation; 6. In addition to the above, the investigator judges that there are other reasons for not being suitable to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HBV DNA negative conversion rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| HBV DNA negative conversion rate;Changes in HBV DNA from baseline;Changes in HBsAg, HBsAb, HBeAg, HBeAb, HBcAb from baseline;Serum HBeAg clearance and HBeAg serological conversion rate;Serum HBsAg clearance and HBsAg serological conversion rate;Improvement level of liver function indexes (ALT?AST?BUN);Changes in liver hardness from baseline;Improved level of renal function indicators (EGFR, SCR); | — |
Countries
China
Contacts
Public ContactLin Chaoshuang
The Third Affiliated Hospital of Sun Yat-sen University
Outcome results
None listed