Chronic Hepatitis B
Conditions
Interventions
PgRNA negative group:discontinue oral antiviral therapy
PgRNA positive group:discontinue or continue oral antiviral therapy
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
Male
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Patients with chronic hepatitis B who are receiving long-term nucleotide or nucleoside anologues: for HBeAg-positive patients, after seroconversion, HBVDNA below the lower limit of detection, ALT recurrence or HBeAg-negative patients, consolidation therapy for at least 1 year, HBVDNA below the lower limit of detection, ALT is recurring and meets the recommended withdrawal criteria for the 2015 China/APASL guidelines.
Exclusion criteria
Exclusion criteria: 1. Patients who had other type hepatitis(including HAVHCVHDVHEV). 2. Patients whose serum alanine aminotransference ALT or Direct bilirubin is over ULN. 3. Previous B-ultrasound found suspicious liver malignancy, or alpha-fetoprotein greater than 100ng/ml; or alpha-fetoprotein could not remain stable within 6 months before the study. 4. Patients with liver cirrhosis whose Child-Pugh score is 7 or above 7 (serum albumin less than 3.5 g/L or PT prolonged >= 3 seconds or SB >34umol/L or history of hepatic encephalopathy or history of esophageal varices bleeding or ascites). 5. Pregnant, lactating women or patients with pregnancy plans and unwilling to contraception during the study period 6. Abuse alchohol (There is evidence of a history of excessive alcohol intake within 1 year: men > 40g / d, women > 40g / d). 7. Patients who have immune disease. 8. Patients with other malignant tumors (excluding those who have been cured). 9. Patients with serious diseases such as heart, lung, kidney, brain, and blood; 10. Have received immunomodulators within 6 months before screening (corticosteroids, thymidine, interferon, etc.); 11. Creatinine is 1.5 times higher than the upper limit of normal (based on our laboratory); 12. Patients who have undergone a liver transplant or plan to undergo a liver transplant; 13. Patients who were considered unsuitable for the study; 14. Patients who participated in other clinical studies at the same time.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HBV RNA;HBV DNA; | — |
Countries
China
Contacts
Public ContactXuezhong Lei
West China Hospital of Sichuan University
Outcome results
None listed