Chronic hepatitis B
Conditions
Interventions
Tenofovir alafenamide Fumarate tablets (TAF) monotherapy:Tenofovir alafenamide Fumarate tablets (TAF) monotherapy
pegylated interferon a-2b combined with TAF:pegylated interferon a-2b combined with TAF
pegylated interferon a-2b pulsed combined with TAF:pegylated interferon a-2b pulsed combined with TAF
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1) Age 18-60 2) HBsAg positive for more than 6 months 3) ALT=40 IU/mL 4) HBeAg (+), 20 < HBV DNA=2*107 IU/mL; Or HBeAg (-), HBV DNA=2*103 5) Patients without previous treatment of chronic hepatitis B (Naive)
Exclusion criteria
Exclusion criteria: 1) Contraindication of interferon 2) Patients with previous treatment of chronic hepatitis B 3) ALT > 40 IU/mL 4) Liver fibrosis/cirrhosis/liver cancer and other malignant tumors 5) Family history of liver cancer 6) There are extrahepatic manifestations of HBV 7) Concomitant diseases including autoimmune diseases, psychosis (depression, etc.), diabetes, thyroid dysfunction 8) Serious underlying diseases: cardiovascular diseases, lung diseases, kidney diseases, brain and fundus diseases 9) Low WBC/WBC in peripheral blood: <2×109/L and/or platelet count <100×109/L, HGB (male) <10 g/dL, HGB (female) < 11 g/dL 10) organ transplantation or preparing for organ transplantation 11) Pregnant women, lactation women and planning pregnant within 2 years 12) Alcoholics or drug addicts 13) Patients with HAV, HCV, HDV, HEV infection and autoimmune liver disease 14) The physician considers that interferon is not suitable treatments
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HBV DNA; | — |
Secondary
| Measure | Time frame |
|---|---|
| HBsAg;HBeAg; | — |
Countries
China
Contacts
Public ContactHong Tang
Outcome results
None listed