hepatitis B
Conditions
Interventions
carriers of hepatitis B virus group:PEG- Interferon alpha 2a
Chronic hepatitis B virus group:PEG- Interferon alpha 2a
Sponsors
Shenzhen Hospital of Peking University
Eligibility
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: (1) Voluntarily join a group, can understand and sign the informed consent; (2) Age from 18 to 65 years old; (3) The body mass index (BMI) in the 17 to 28 range; (4) HBV serological requirements:the HBsAg positive history of at least 6 months By screening positive for HBsAg, and 20-20000IU/ml HBV-DNA quantitative IU/ml (or the equivalent of the viral load); (5) screening (disable Hugan Jiangmei drugs for at least 2 weeks) in normal ALT or less than 10*ULN; (6) Women of childbearing age: urine pregnancy test was negative, and the subjects (including male subjects) to the next 18 months without pregnancy plan and take effective contraceptive measures; (7) the interferon (2~8C) low temperature storage conditions.
Exclusion criteria
Exclusion criteria: Comply with any of the following criteria are not allowed into the group: (1) Pregnant, lactating women or during the study period have fertility planners; (2)Who had previously received interferon treated; (3) screening who received nucleoside (acid) analogue therapy or had nucleoside (acid) analogues in treatment resistant history 6 months before; (4) 6 months before screening had strong immune regulators (such as the adrenal cortex hormones, thymosin alpha 1, 5 thymus peptide etc.) for more than 2 weeks; (5) 6 months before screening had been taking drugs liver toxicity (such as dapsone, fluconazole, ketoconazole, erythromycin, rifampicin equality) for more than 2 weeks; (6) Who caught or catching other viruses (HAV, HCV, HDV, HEV, HIV) infection; (7)Who have liver disease caused by other reasons: including chronic alcoholic hepatitis, drug hepatitis, autoimmune liver disease; (8)Who have neuropsychiatric disorders, including depression, anxiety, mania, family history of mental illness such as schizophrenia or history of mental illness (especially depression disease history or depression tendency); (9) Screening with acute infectious disease or the researchers estimate that do not fit into the group of untreated chronic infectious diseases; (10) Autoimmune diseases, including psoriasis, systemic lupus erythematosus; Mild cardiovascular disease is not controlled, or moderate cardiovascular disease; (12) Diseases of the endocrine system, including a failure to good control of thyroid disease, diabetes; (13) lung disease, such as bronchitis, lung disease, such as infiltration; (14) of fundus diseases, such as retinal lesions; (15) renal disease: acute and chronic nephritis, renal insufficiency, and nephrotic syndrome; (16) any uncontrolled peptic ulcer, colitis, pancreatitis, cholecystitis; (17) Have hepatocellular carcinoma (HCC) or suspected hepatocellular carcinoma and other malignant tumors; (18) abnormality of laboratory examination:Peripheral blood neutrophil count: less than 1.5*10^9/L, platelet count less than 90*10^9/L; Liver function: serum total bilirubin more than 2 times the normal reference values of serum albumin (ULN); less than 35g/L; compared with the normal reference values of prothrombin time (ULN) prolonged for more than 3 seconds; prothrombin activity less than 60%; had decompensated cirrhosis evidence; screening of liver function in the Child-Pugh class B or greater etc.;Renal function: the upper limit of the normal reference values of serum creatinine (ULN) Other: serum creatine kinase (CK) more than 2 times the normal reference values (ULN), if CK more than 2 times ULN and obvious effect of exercise physiological factors such as can be in 2 weeks later, if it is still 2 times higher than ULN is not in group; (19) One year before screening drug addiction evidence (including excessive alcohol intake: equivalent to the amount of alcohol for male more than 40g/d, female more than 20g/d, average alcohol consumption equals 50 degrees liquor respectively 100ml/day and 50ml/day); (20) The food, drug allergies or allergic constitution is serious, especially for interferon or its ingredient allergy; (21) HBsAg and anti -HBs and anti-HBe positive or HBeAg positive people and at the same time; (22) Who plans to accept organ transplant or have had organ transplants; (23) The clinical test before 6 months in other drugs; (24)The researchers judged unsuitable for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HBV-DNA;HBsAg, HBeAg; | — |
Secondary
| Measure | Time frame |
|---|---|
| ALT;T lymphocyte count;Actived CD25 T lymphocyte;T/B/NK cells;Liver Tissue; | — |
Countries
China
Contacts
Public ContactPeng Yanzhong
Outcome results
None listed