Hepatitis B Virus
Conditions
Keywords
hepatitis B virus, nucleoside, nucleotide
Brief summary
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.
Detailed description
Hepatitis b virus infection has always been a global public health problem that endangers national health. Current clinical guidelines do not recommend antiviral therapy for people with positive hepatitis b-DNA and normal Alanine Aminotransferase, but studies have found that viral replication is associated with an increased risk of cirrhosis and liver tumors. Nucleoside (acid) analogues can effectively inhibit viral reverse transcriptase, reduce HBV viral load in the blood, thereby reducing secondary inflammation, and contribute to liver cell regeneration and disease recovery. And its side effect is small, adverse reaction rate is low, use safety.
Interventions
Patients would receive treatment of oral Tenofovir alafenamide Fumarate（TAF）once per day.
Sponsors
Third Affiliated Hospital, Sun Yat-Sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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); * Do not receive nucleotide/nucleoside analogues or interferon treatment in the past half year.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| hepatitis b s antigen decrease from baseline | 48 week, 96 week, 144 week | Magnitude of decrease in hepatitis B antigen quantification from baseline to week 144. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| hepatitis b e antigen loss rate | 48 week, 96 week, 144 week | 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 | 48 week, 96 week, 144 week | Hepatitis b virus DNA would not be detected if it below the upper limit of test value |
| hepatitis b virus(HBV) RNA undetectable rate | 48 week, 96 week, 144 week | Hepatitis b virus RNA would not be detected if it below the upper limit of test value |
| hepatitis b s antigen loss rate | 48 week, 96 week, 144 week | Hepatitis b s antigen become negative and quantitative analysis below the upper limit of test value |
Countries
China
Contacts
Primary ContactQiumin Luo, Doctor
Backup ContactLiang Peng, Doctor
Outcome results
None listed