chronic hepatitis B
Conditions
Interventions
the combination therapy group:NA
NAs monotherapy group:NA
Sponsors
The First People’s Hospital of Yunnan Province
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-60 years old; 2. Comply with the clinical diagnostic criteria in the "Guidelines for the Prevention and Treatment of Chronic Hepatitis B" (2022 Edition) regarding the HBeAg-positive chronic hepatitis B virus infection. That is, HBsAg positive >6 months, qHBsAg > 1x10^4IU/ml, HBeAg positive, HBV DNA > 2x10^7IU/ml, ALT below the upper limit of normal value (each center according to its detection limit as the standard, except for the screening period, there is at least one previous normal ALT evidence, "past" is 3 months or more). No obvious evidence of inflammatory necrosis or fibrosis of the liver (pathology below G2 and S2 or liver stiffness < 7.3kPa, APRI < 1, FIB-4 < 1.45); 3. no antiviral therapy within the preceding 6 months 4. For patients of childbearing age, agree to choose appropriate contraceptive measures (including at least one barrier contraceptive method) throughout the trial period; 5. Volunteer to join this study and sign an informed consent form.
Exclusion criteria
Exclusion criteria: (1) combined liver diseases caused by other causes, such as HAV, HCV, HDV, HEV infection, severe fatty liver, autoimmune liver disease, drug-induced hepatitis, etc. (2) Patients with uncontrolled diabetes, hypertension, severe heart disease, epilepsy, psychiatric history, thyroid disease, retinopathy, autoimmune disease, HIV antibody positive, etc (3) Suspected or do have a history of alcohol or drug abuse; (4) Pregnant and lactating women; (5) Neutrophil count 34umol/L (6) Patients who have progressed to liver cirrhosis or liver cancer; (7) Subjects who are unsuitable to participate in the research based on the researcher's judgment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HBeAg Seroconversion rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| HBsAg loss rate;the undetectable rate of HBV DNA;liver cirrhosis rate;HCC incidence rate;he proportion of participants with HBsAg levels <1000 IU/ml at week 48/72/96; | — |
Countries
China
Contacts
Public ContactJiawei Geng
The First People’s Hospital of Yunnan Province
Outcome results
None listed