chronic viral hepatitis B
Conditions
Interventions
A:Tenofovir fumarate dipyrifuroxime
B:Tenofovir fumarate dipyrifuroxime+therapeutic vaccine YIC
Sponsors
Union Hospital of Tongji Medical College; Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Willing to sign informed consent; 2. Aged between 18 and 65 years; 3. Chronic hepatitis B patients with a clear medical history and treatment history were treated with nucleoside analogs for 1 to 5 years, and the initial treatment met the antiviral indications; 4. HBsAg<3000IU/ml; 5. PCR was negative for HBV DNA; 6. ALT was within twice the normal range; 7. Child-bearing women HCG test of blood or urine were negative. Effective measure must be used to protected reproductive-age people from having children during the period of entering screening to three months after the study is completed.
Exclusion criteria
Exclusion criteria: (1) Patients have a history of resisting TDF; (2) Pregnant or lactating women; (3) The patient had severe hepatitis in the past two years; (4) Patients were treated with interferon or powerful immunomodulators, such as adrenocortical hormone, thymosin alpha 1 and thymosin 5,within 6 months before enrollment; (5) Co-infection with other viruses: positive for any of anti-hav IgM, anti-HCV, anti-HDV, anti-HEV and anti-HIV; (6) A history of allergy to vaccines or other immune agents or drugs; (7) A history of autoimmune disease or thyroid dysfunction; (8) Patients had taken hepatotoxic drugs for a long time within the 6 months before selection; (9) The patient is suspected of cirrhosis, or compensatory cirrhosis; (10) The patient was suspected to have primary liver cancer or AFP>100ng/ml; (11) Other liver diseases include chronic alcoholic hepatitis, drug-induced hepatitis, autoimmune hepatitis (antibody titer higher than l:100), Wilson's disease and hemochromatosis; (12) Any other serious diseases except hepatitis that the investigators believe may affect the patient's treatment, follow-up, or evaluation.Including any uncontrolled diseases of heart, lung, kidney, digestive system, neurological system, psychiatric disorder,abnormal autoimmunity regulation, metabolic disorders or malignant tumor; (13) Serum creatinine was higher than the upper limit of 1.5 normal value; (14) Platelet was lower than 80,000,000,000/L; (15) White blood cell was lower than 3,000,000,000/L; (16) Hemoglobin <11.5g/dL (female), <12.5g/dL (male); (17) ALT was higher than the upper limit of twice the normal range; (18) Evidence of drug addiction (including excessive alcohol intake)within one year before enrollment; (19) Other drugs under research were accepted within 3 months before screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| negative conversion rate of HBsAg; | — |
Secondary
| Measure | Time frame |
|---|---|
| cell-mediated immune responses;HBsAg conversion rate;HBeAg conversion rate; | — |
Countries
China
Contacts
Public ContactXuan-Yi Wang
Shanghai Medical College of Fudan University
Outcome results
None listed