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
Third Affiliated Hospital, Sun Yat-Sen University
200 participants
Jun 4, 2020
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- 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 Criteria4
- 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.
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Interventions
Patients would receive treatment of oral Tenofovir alafenamide Fumarate（TAF）once per day.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT04231565