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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    100
  • sponsor
    Third Affiliated Hospital, Sun Yat-Sen University
Updated on 24 February 2022

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.

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.

Details
Condition Hepatitis B Virus
Treatment Tenofovir alafenamide Fumarate
Clinical Study IdentifierNCT04231565
SponsorThird Affiliated Hospital, Sun Yat-Sen University
Last Modified on24 February 2022

Eligibility

Yes No Not Sure

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) 1ULN 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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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