chronic hepatitis B
Conditions
Interventions
HBeAg positive:no
Sponsors
Beijing Youan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 60 years old; 2. compensated liver function(no ascites, hepatic encephalopathy or upper gastrointestinal bleeding, etc.); 3. previously used conventional interferon-a (Interferon-a, IFN-a) (PegIFN-a), the use of the last dose of interferon need to be within a time interval of = 6 months; 4. HBeAg-positive chronic hepatitis B, long-term treated with NAs, the patients should be consistent with the European Association for the Study of the Liver(EASL)Chronic Hepatitis B practice guidelines (2017 version) discontinuation criteria: HBeAg seroconversion, HBV DNA undetectable (recruiment screen required using roch diagnostic reagent, with a lower HBV DNA limit of 20 IU/ml), consolidation therapy for at least 1 year; 5. HBeAg-negative chronic hepatitis B, long-term treatment of NAs, the patient required to comply with the European Association for the Study of the Liver(EASL)Chronic Hepatitis B practice guidelines (2017 version) discontinuation criteria: HBV DNA can not be detected for more than 3 years (Roche cobas HBV kit is required for screening, the detection limit of HBV DNA is 20 IU/ml); 6. Pregnancy test in childbearing age women is negative; 7. Preferentially enrolled subjects with serum (or plasma) specimens within half a year prior to discontinuation of NAs; 8. To obtain informed consent from the subject.
Exclusion criteria
Exclusion criteria: 1. combined with other viral infections, such as Hepatitis A, Hepatitis C, Hepatitis D, Hepatitis E, HIV; or other causes of liver injury, such as autoimmune liver disease, drug-induced liver Injury, alcoholic liver disease, hereditary metabolic liver disease, fatty liver disease, etc.; 2. In addition to hepatitis B with other serious physical and mental diseases, including uncontrolled primary kidney, heart, lung, vascular, neurological, digestive and metabolic diseases (with obvious hyperthyroidism, severe diabetes and adrenal diseases), immunodeficiency diseases, severe infections, retinal diseases, etc.; 3. Those with previous history of cirrhosis (including those with a history of liver cirrhosis before NAs treatment), or Imaging studies such as ultrasonography or CT screening prior to or at screening suggest cirrhosis, or any of the following: LSM =12.0 kPa, or aspartate aminotransferase and platelet ratio index (APRI)> 2 points, or recently 1 year liver pathology indicated cirrhosis; 4. past history with hepatocellular carcinoma, or screening with suspected hepatocellular carcinoma, such as imaging suspicious nodules, or AFP> 50ng / mL; 5. a history of suspected malignancies or malignancies in the past 5 years; 6. a recent history of drug abuse or substance abuse, alcohol abuse, which researchers consider that obstructive to compliance with the protocol; 7. 6 months prior to enrollment,patietns receiving corticosteroids, immunosuppressive agents, and chemotherapy drugs; 8. receiving trial medication within the last 3 months; 9. women having pregnancy plans or lactation plan during the study; 10. Patients with mental disorder or poor compliance; or other conditions that the investigator considered inappropriate to enrolled.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HBV RNA; | — |
Secondary
| Measure | Time frame |
|---|---|
| Hepatic histopathology; | — |
Countries
China
Contacts
Public ContactSujun Zheng
Beijing Youan Hospital, Capital Medical University
Outcome results
None listed