chronic hepatitis b (CHB)
Conditions
Interventions
A:pegylated interferon combined with entecavir
B: pegylated interferon combined with tenofovir
Sponsors
The Fourth Affiliated Hospital of Medical College of Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18-65 years old; 2. Patients with HBsAg positive > for 6 months and hbeag-positive CHB; 3. The HBV DNA of the patient could not be detected after the treatment with two nucleoside analogues (entecavir or tenofovir) for 12 months; 4. Serum ALT was normal or elevated when HBsAg 1500IU/ml; B ultrasound showed no cirrhosis. 6. Normal functioning of major organs means that they meet the following criteria: (1) blood routine examination standards shall meet: A. HB 90 g/L or higher; B. the ANC acuity 1.5 x 109 / L; C. PLT acuity 80 x 109 / L; (2) biochemical examination shall meet the following standards: A. TBIL 45 ml/min (Cockcroft-Gault formula); 7. Women of child-bearing age must have a reliable method of contraception or a pregnancy test (serum or urine) conducted within 7 days of enrollment, which is negative. In addition, all men and women of child-bearing age are willing to use an appropriate method of contraception during the trial and 8 weeks after the last administration of the test drug. 8. Subjects voluntarily participated in this study and signed the informed consent, with good compliance and follow-up.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women; 2. Liver cirrhosis decompensated period or contraindication of interferon local treatment, patients with pegylated interferon or NAs allergy; 3. Positive screening for hepatitis c virus immunoglobulin M antibody, hepatitis c virus RNA or hepatitis c virus antibody, hepatitis d virus antibody or HIV antibody; 4. Patients diagnosed with liver cancer; 5. In addition to viral hepatitis, there is other medical history or evidence related to chronic liver diseases (such as hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposure, thalassemia); 6. Women who are pregnant or breastfeeding; 7. Patients with a history of major organ transplantation; 8. History of immune diseases (such as inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, rheumatoid arthritis, etc.); 9. Patients with hypertension who cannot be reduced to the normal range by antihypertensive drugs (systolic blood pressure >140 mmHg, diastolic blood pressure >90 mmHg) have grade I or above myocardial ischemia or myocardial infarction, arrhythmia (including QT interval 440 ms) and grade II cardiac dysfunction; 10. Having obvious factors affecting oral drug absorption, such as inability to swallow, chronic diarrhea and intestinal obstruction; 11. Abnormal coagulation function (INR >1.5 or PT > ULN+4 seconds or APTT > 1.5uln), with bleeding tendency or receiving thrombolytic or anticoagulant treatment; 12. Patients with a history of thyroid disease: poorly controlled prescription drugs, elevated levels of thyroid stimulating hormone (TSH), elevated thyroid peroxidase antibodies, and clinical manifestations of any thyroid disease; 13. Have a history of psychotropic substance abuse and cannot quit or have a mental disorder; 14. Participated in clinical trials of other drugs within 4 weeks; 15. The investigator judges other conditions that may affect the progress of clinical research and the judgment of research results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HBsAg; | — |
Countries
china
Contacts
Public ContactHuang Guangyu
The Fourth Affiliated Hospital of Medical College of Zhejiang University
Outcome results
None listed