chronic hepatitis B
Conditions
Interventions
intervention group:antiviral therapy
control group:N/A
Sponsors
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Between the ages of 18 and 65, there is no restriction on male or female; (2) HBV DNA positive, ALT < ULN, compensatory liver disease; (3) HBsAg positive for at least 6 months before treatment; (4) Antiviral treatment failure; (5) Female subjects need to take effective contraceptive measures during the treatment period, and pregnant or lactating women cannot be included in the group; (6) All subjects should sign the written informed consent.
Exclusion criteria
Exclusion criteria: (1) Prepare to screen antiviral drugs within 30 days before participating in the study; (2) ALT > 1 x the upper limit of normal value occurred in the past 30 days and confirmed by medical records; (3) History of decompensated liver cirrhosis (ie, liver cirrhosis combined with jaundice, ascites, gastrointestinal bleeding or hepatic encephalopathy caused by esophagus-gastric varices); (4) Subjects with neutropenia (neutrophils 50 ng/ml; (8) Hyperthyroidism or hypothyroidism (if all other inclusion/exclusion criteria are met, patients who maintain TSH within a normal level through drug therapy can be selected); (9) Receive immunosuppressive therapy within 6 months before enrollment; (10) Other serious medical diseases that may affect this study: severe respiratory insufficiency in the previous 6 months, malignant tumors except basal cell carcinoma of the skin in the previous 5 years, immunodeficiency diseases (for example: HIV positive, autoimmune diseases, or other organ transplants except corneal or hair transplants); (11) Systemic diseases that may require steroid treatment due to medical needs during the study period; (12) Substance abuse in the past 2 years, such as alcohol abuse (>=80 g/day), intravenous injection or inhalation of drugs; (13) Any situation that the investigator considers may affect the patient's enrollment, participation or completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| anti-HBc;HBV RNA;HBV DNA; | — |
Countries
China
Contacts
Public ContactWang Hui
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed