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RECRUITINGINTERVENTIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - Other active liver diseases; - Hepatocellular carcinoma or other malignancy; - Pregnancy or lactation; - Human weakened immune system virus infection or congenital immune deficiency diseases; 5.Severe diabetes, autoimmune conditions (where your immune system attacks your own body)s; 6.Other important organ dysfunctions; 7.Using glucocorticoid; 8.Patients can not follow-up; 9.Investigator considering inappropriate. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

Tenofovir alafenamide Fumarate

Patients would receive treatment of oral Tenofovir alafenamide Fumarate（TAF）once per day.

Locations (1)

Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China