chronic hepatitis B
Conditions
Interventions
Control group:Polyethylene glycol interferon alpha-2b + nucleoside (acid) analogue
Test group:Gansan Decoction + Polyethylene glycol interferon alpha-2b + nucleoside (acid) analogue
Sponsors
Hospital of Chengdu University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1) Age 18~60 years old, male and female (including 18 and 60 years old); 2) HBsAg positive for more than 6 months, HBsAg <1,500 IU/mL and HBV-DNA =2,000 IU/mL; 3) Nucleoside analogue therapy for more than 6 months and currently receiving nucleoside analogue therapy; 4) ALT consistently normal (<30U/L for men and <19U/L for women) 5) willingness to accept treatment and sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1) Comorbid active hepatitis A, C, D, E and/or HIV infection; 2) Patients with prior interferon therapy; 3) decompensated liver disease (Child-Pugh score = 5), meaning that patients will be excluded if one of the following is met: serum albumin 34umol/L, history of hepatic encephalopathy, history of oesophageal variceal bleeding, ascites; 4) Pregnant or breastfeeding women or patients who plan to become pregnant during the study period and who are unwilling to use contraception; 5) Neutrophil count <1.5 x 109L (2 x 109L) or platelet count <90 x 109L (100 x 109L). Those with muscle intoxication higher than 1.5 times the upper limit of normal; 6) History of severe psychiatric illness, especially depression. Severe psychiatric illness is defined as major depression or psychosis, suicide attempts, hospitalisation for psychiatric illness, or a period of incapacity due to psychiatric illness; 7) history of immune-mediated disease (e.g. inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune haemolytic anaemia, scleroderma, severe psoriasis, rheumatoid arthritis) or abnormally elevated levels of autoimmune antibodies; 8) Patients with serious diseases of heart, lung, kidney, brain, blood and other important organs, and patients with other malignant tumours; 9) Patients with a history of severe epilepsy or currently using antiepileptic drugs. Unstable control of diabetes mellitus, hypertension, thyroid disease, etc. Patients with a history of severe retinopathy or indicated by other evidence of retinopathy; 10) History of any organ transplantation and existing functional grafts (other than corneal or hair transplants); 11) Patients who are allergic to interferon and its pharmaceutical components and who, in the judgement of the investigator, are not suitable for interferon application; 12) Patients who, in the judgement of the investigator, are not suitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HBsAg serological negative conversion rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Lymphocyte subgroup count;Expression rate of PD-1 in lymphocytes;Expression rate of PD-L1 in lymphocytes;TNF-a;IL-8;Serum arginine;Serum alanine aminotransferase;Serum HBsAg titer;Serum HBV-DNA ;Serum pgRNA;Liver hardness value;routine blood test;Six items of thyroid gland; | — |
Countries
China
Contacts
Public ContactHu Xiaoyu
Hospital of Chengdu University of Traditional Chinese Medicine
Outcome results
None listed