chronic hepatitis B
Conditions
Interventions
Sponsors
The First Affiliated Hospital of Nanchang University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) Must be able to understand and sign the written informed consent, which must be obtained before screening; 2) Male and non-pregnant, non-lactating female subjects who have reached the age of 18-65 (subject to the date of signing the informed consent). The serum pregnancy test of female subjects of childbearing age is negative; 3) Signs of chronic HBV infection recorded (for example, HBsAg positive for more than 6 months or hepatitis B carrier history for many years, or those who have not had physical examination but abdominal imaging shows splenomegaly), 1000 IU/mL=HBsAg level=6000IU /mL. 4) Liver function and HBV DNA requirements during screening: serum 1ULN <ALT level=10ULN (40U/L), 2X102IU/mL=serum HBV DNA=1X106IU/mL. 5) Treatment-naive subjects (never received any nucleoside or nucleotide analogue oral antiviral therapy) or treated subjects (interferon treatment or any nucleoside or nucleotide analogue drug therapy) must have ended at least 6 months prior to the baseline visit to be eligible for study entry. 6) Must be willing and able to comply with all research requirements.
Exclusion criteria
Exclusion criteria: 1) Pregnant women, lactating women or female patients who plan to become pregnant during the study; 2) Men and women with childbearing potential who are unwilling to use the "effective" contraceptive method stipulated in the protocol during the study period; 3) Co-infection with HCV, HIV or HDV; 4) Hepatocellular carcinoma diagnosed by imaging (with evidence of hepatocellular carcinoma); 5) Patients who have received solid organ or bone marrow transplantation; 6) There is a history of malignant tumors within 5 years before screening, except for specific tumors cured by surgical resection (basal cell skin cancer, etc.); patients who are evaluated as possible malignant tumors are not eligible; 7) Currently receiving treatment with immunomodulators (such as corticosteroids), research drugs, nephrotoxic drugs or drugs that can adjust renal excretion; 8) Serious renal, cardiovascular, pulmonary or neurological diseases considered by the investigator; 9) Severe bone disease (such as osteomalacia, chronic osteomyelitis, osteogenesis imperfecta, osteomalacia) or multiple fractures; 10) Subjects receiving contraindicated combined drugs (subjects receiving prohibited drugs will require a washout period of at least 30 days) and known hypersensitivity reactions to study drugs, metabolites or formulation excipients; 11) According to the investigator's judgment, the current drinking or substance abuse may interfere with the subject's compliance with the research requirements; 12) Any other clinical illness or previous treatment that the investigator believes will make the subject unsuitable for participating in the study or unable to comply with the medication requirements. 13) Abnormal hematological and biochemical parameters, including: hemoglobin 10×ULN; total bilirubin > 2.5×ULN; albumin 1.5; (unless stabilized on anticoagulant regimen)
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| ALT normalization;pgRNA;degree of liver fibrosis;HBsAg turns negative; | — |
Primary
| Measure | Time frame |
|---|---|
| HBV-DNA negative conversion rate; | — |
Countries
China
Contacts
Public ContactXiaoping Wu
The First Affiliated Hospital of Nanchang University
Outcome results
None listed