Chronic hepatitis B
Conditions
Interventions
Group A (Continuous Combination Therapy Group):From the first day of baseline, TAF was taken orally once a day until the time when the drug could be stopped. At the same time, 180µg of Peg-IFN a-2b wa
Group B (Pulse Combination Therapy Group):From the first day of baseline, TAF was taken orally once a day until the time when the drug could be stopped. At the same time, Peg-IFN a-2b 180µg/week is us
Sponsors
Ji'nan Infectious Disease Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-50 (including 18 and 50) years, no gender unlimited; 2. HBsAg (+), and the course of disease was more than half a year; 3. Patients with chronic hepatitis B with Negative HBeAg and alt >= 2 times of the upper normal value (or pathological changes of G2 or S2 or above in liver biopsy); 4. The results showed that the urine pregnancy test was negative before the test and effective contraceptive measures were taken in the female subjects during the childbearing period, and the contraception was unified during and half a year after the treatment (including female partners of female and male patients); 5. Willing to receive treatment and sign informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients who have received standard interferon therapy (defined as continuous use of interferon for more than 3 months) in the past; 2. They had received nucleoside (acid) analogue treatment within 6 months before screening; 3. Known to be allergic to interferon and nucleoside antiviral drugs; 4. Patients infected with other viruses such as HAV, HCV, HDV, HEV and HIV; 5. Liver cirrhosis or child Pugh score 7 or above; 6. History or evidence of liver disease caused by other causes (such as autoimmune liver disease, alcoholic liver disease, nonalcoholic fatty liver disease, drug-induced hepatitis, hepatolenticular degeneration, etc.); 7. Pregnant or lactating women; 8. There was a history of alcohol or drug abuse within one year before the screening; 9. Neutrophil count = 7; 13. History of endocrine system or autoimmune diseases, such as thyroid disease, diabetes, systemic lupus erythematosus, sarcoidosis, autoimmune thrombocytopenic purpura, etc; 14. Chronic diseases requiring long-term treatment, such as hypertension, diabetes, chronic obstructive pulmonary disease, etc; 15. Malignant tumor; 16. At the time of screening, suspected liver malignant tumor was found by B-ultrasound, or AFP was more than 100 ng / ml, or AFP could not remain stable within 3 months before the test; 17. History of organ transplantation; 18. Other diseases considered unsuitable for inclusion by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HBsAg clearance rate at the end of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion and recurrence rate of patients with HBsAg < 10 IU / ml at the end of treatment;The proportion and recurrence rate of patients with HBsAg < 100 IU / ml at the end of treatment;The proportion and recurrence rate of patients with HBsAg < 1000 IU / ml at the end of treatment; | — |
Countries
China
Contacts
Public ContactJiang Xuemei
Ji'nan Infectious Disease Hospital
Outcome results
None listed