Hepatitis B
Conditions
Interventions
Group A :TMF 25mg/ time, oral
Group B:None
Sponsors
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Must be able to understand and sign written informed consent, which must be obtained before screening; 2.Male subjects aged 18 to 65 years (subject to the date of signing informed consent) and non-pregnant and non-lactating female subjects. Serum pregnancy test was negative in female subjects of childbearing age; 3.Documented signs of chronic HBV infection (e.g., HBsAg positive for more than 6 months); 4.The recorded chronic HBV infection with normal ALT should meet the following requirements: serum HBV DNA > 20 IU/mL, serum ALT level <=ULN (40IU/ mL); 5.Not treated subjects (never accept any oral antiviral nucleoside or nucleotide analogue therapy) or treated subjects (any nucleoside or nucleotide analogues, and interferon treatment (including polyethylene glycol (PEG) and non-polyethylene glycol must be at least 6 months before the baseline visit end), will be able to be included in the study; 6.Must be willing and able to comply with all research requirements.
Exclusion criteria
Exclusion criteria: 1.Pregnant women, breast-feeding women or women who plan to become pregnant during the study period; 2.Men and women with reproductive potential who were not willing to use an "effective" contraceptive method specified in the protocol during the study period; 3.Patients with HCV, HEV, HIV or HDV, or with autoimmunity liver, metabolism-related fatty liver disease, drug-induced liver injury; 4.Imaging diagnosis of hepatocellular carcinoma (evidence of hepatocellular carcinoma); 5.Patients with cirrhosis, including compensatory cirrhosis and evidence of past or existing clinical decompensation of liver function (e.g., ascites, hepatic encephalopathy, or bleeding from esophagogastric varices); 6.Abnormal hematological and biochemical parameters, including: hemoglobin 10xULN; total bilirubin >2.5xULN; albumin 1.5xULN (unless stabilized in anticoagulant regimens); creatinine clearance (CLCr) was less than 50mL/min; 7.Patients who have received solid organ or bone marrow transplants; 8.Have a history of malignant tumor within 5 years prior to screening, except for specific tumors (basal cell skin cancer, etc.) that have been cured by surgical resection; Patients assessed as possible malignancies are not eligible; 9.Currently receiving treatment with immunomodulatory agents (such as corticosteroids), research drugs, nephrotoxic drugs, or drugs that regulate renal excretion; 10.Combined with uncontrollable cardiovascular and cerebrovascular diseases; 11.Subjects receiving contraindicated drugs (subjects receiving contraindicated drugs will require a washout period of at least 30 days) and any known hypersensitivity to the study drug, metabolite or formulation excipient; 12.In the investigator's judgment, current alcohol or substance abuse may interfere with the subjects' compliance with study requirements; 13.Prior treatment for any other clinical condition that the investigator believes would make the subject unfit for study participation or unable to comply with medication requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects with serum HBV DNA<20 IU/mL (cobas); | — |
Secondary
| Measure | Time frame |
|---|---|
| The decrease of HBV DNA ;Proportion of subjects with negative HBeAg conversion (HBeAg positive subjects);Proportion of subjects with negative HBeAg conversion and serum conversion to anti-HBE antibody (HBEAg-positive subjects);Proportion of subjects with HBsAg turning negative;Proportion of subjects with HBsAg turning negative and serum converting to anti-HBS antibody ;Quantitative decrease of HBsAg ;Incidence of drug-resistant mutations ;Changes in liver fibrosis from baseline ;Proportion of subjects with acute hepatitis attack (ALT >5 ULN (40IU/ml)) during the study period; | — |
Countries
China
Contacts
Public ContactChen Yangyang
Jiangsu Hanson Pharmaceutical Group Co.,Ltd
Outcome results
None listed