Nucleoside (Acid) Analogues Treatment in Patients With Normal ALT and Positive HBVDNA.

Study Overview
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Brief Summary
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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
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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.

Official Title
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Study on Therapeutic Effects and Safety of Nucleoside (Acid) Analogues Treatment in Patients With Chronic Hepatitis B With Normal Alanine Aminotransferase and Positive Hepatitis B Virus DNA: a Randomized Controlled Trial

Conditions
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Hepatitis B Virus

Intervention / Treatment
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* Drug: Tenofovir alafenamide Fumarate


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TAF group<br>50 patients would receive treatment of oral Tenofovir alafenamide Fumarate(TAF) 25 mg once per day from baseline to life-long. | Drug: Tenofovir alafenamide Fumarate<br>* Patients would receive treatment of oral Tenofovir alafenamide Fumarate（TAF）once per day.<br>* Other names: Vemlidy;|
| No Intervention: Observation group<br>50 patients would not receive treatment from baseline to life-long. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hepatitis b s antigen loss rate | Hepatitis b s antigen become negative and quantitative analysis below the upper limit of test value | 144 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 0 week,12 week,24 week,36 week,48 week,72 week,96 week,120 week,144 week | 
| hepatitis b virus(HBV) DNA undetectable rate | Hepatitis b virus DNA would not be detected if it below the upper limit of test value | 0 week,12 week,24 week,36 week,48 week,72 week,96 week,120 week,144 week | 
| hepatitis b virus(HBV) RNA undetectable rate | Hepatitis b virus RNA would not be detected if it below the upper limit of test value | 0 week,12 week,24 week,36 week,48 week,72 week,96 week,120 week,144 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hepatitis B virus, nucleoside, nucleotide