About this trial
This study is to investigate the clinical efficacy and safety of Nucleoside (acid) analogues treatment in patients with normal Alanine Aminotransferase and positive Hepatitis B virus DNA.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Positive hepatitis b surface antigen and hepatitis b antibody > 0.5 year;
Age from 18 to 65 years old;
Serum Alanine Aminotransferase(ALT) ≤1×ULN at least 12 weeks;
Positive Hepatitis b virus(HBV);
Disqualifiers
Other active liver diseases;
Hepatocellular carcinoma or other malignancy;
Pregnancy or lactation;
Human immunodeficiency virus infection or congenital immune deficiency diseases; 5.Severe diabetes, autoimmune diseases; 6.Other important organ dysfunctions; 7.Using glucocorticoid; 8.Patients can not follow-up; 9.Investigator considering inappropriate.
Trial design
Parallel
Treatments tested in this trial
Tenofovir alafenamide Fumarate
DrugPatients would receive treatment of oral Tenofovir alafenamide Fumarate(TAF)once per day.
Treatment groups
Trial outcomes
Primary outcomes
hepatitis b s antigen decrease from baseline
Magnitude of decrease in hepatitis B antigen quantification from baseline to week 144.
Secondary outcomes
hepatitis b e antigen loss rate
Hepatitis b e antigen would be tested to know the ratio of patients with negative hepatitis B e antigen.
hepatitis b virus(HBV) DNA undetectable rate
Hepatitis b virus DNA would not be detected if it below the upper limit of test value
hepatitis b virus(HBV) RNA undetectable rate
Hepatitis b virus RNA would not be detected if it below the upper limit of test value
hepatitis b s antigen loss rate
Hepatitis b s antigen become negative and quantitative analysis below the upper limit of test value
Sponsors and contacts
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