chronic hepatitis B
Conditions
Interventions
group 1:enticavir
group 2:tenofovir disoproxil fumarate
group 3:alafenamide tenofovir
Sponsors
Shanghai Public Health Clinical Center
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged between 18 and 75 (including 18 and 75) years; 2. Diagnosed chronic hepatitis B patients, defined as HBsAg positive for at least 6 months and anti-HBs negative; have not received any nucleoside (acid) analog therapy; 3. The urine or serum pregnancy test results are negative 1 week before the first test drug administration (for women of childbearing age) and the patients (including male patients) are willing to take effective contraception for at least 3 months after the treatment and the end of the drug ; 4. Ability and willingness to provide informed consent and comply with trial requirements.
Exclusion criteria
Exclusion criteria: 1. Positive anti-HAV IgM, HCV RNA or anti-HCV, anti-HDV, anti-HEV or anti-HIV test results at screening; 2. Patients who are taking lipid-lowering drugs; patients with uncontrolled cardiovascular and cerebrovascular diseases; 3. There is evidence of decompensated liver disease (Child-Pugh score >= 5); 4. Medical conditions caused by chronic liver disease or other evidence that it is caused by chronic liver disease (such as hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposure, etc.); 5. Alpha-fetoprotein is greater than 100ng/mL at the time of screening, or alpha-fetoprotein cannot remain stable within 3 months before the test and/or liver imaging examination indicates liver tumor; 6. Pregnant or lactating patients; 7. There is evidence that a history of excessive alcohol intake within 1 year, male > 40 grams / day, female > 40 grams / day; 8. Patients with serious diseases of the heart, lung, kidney, brain, blood and other important organs; 9. Patients with creatinine higher than the upper limit of normal; patients with other malignant tumors (excluding those who have been cured); 10. The history of serious disease or other evidence shows that it is a serious disease or has any other disease that makes the investigator think that the patient is not suitable to participate in the trial; 11. Patients who participate in other clinical research trials at the same time.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| total cholesterol;triglyceride;high density lipoprotein;low density lipoprotein; | — |
Countries
China
Contacts
Public ContactQi Xun
Shanghai Public Health Clinical Center
Outcome results
None listed