An interventional study of Tenofovir alafenamide Fumarate in Hepatitis B Virus, sponsored by Third Affiliated Hospital, Sun Yat-Sen University. Recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-03-01.
Sponsored by Third Affiliated Hospital, Sun Yat-Sen University · Not applicable, Interventional, and Treatment
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.
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.
2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.
This study's planned enrollment of 200 is above the median of 100 across 1,886 interventional studies indexed under Hepatitis A.
Browse Hepatitis A studies →Third Affiliated Hospital, Sun Yat-Sen University is the lead sponsor of 130 studies on the registry; 34 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
100 patients would receive treatment of oral Tenofovir alafenamide Fumarate(TAF) 25 mg once per day from baseline to life-long unless the patient achieves HBsAg loss.
Drug: Tenofovir alafenamide Fumarate
100 patients would not receive treatment from baseline to life-long.
Patients would receive treatment of oral Tenofovir alafenamide Fumarate（TAF）once per day.
Also known as: Vemlidy
hepatitis b s antigen decrease from baseline
Magnitude of decrease in hepatitis B antigen quantification from baseline to week 144.
Time frame: 48 week, 96 week, 144 week
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.
Time frame: 48 week, 96 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
Time frame: 48 week, 96 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
Time frame: 48 week, 96 week, 144 week
hepatitis b s antigen loss rate
Hepatitis b s antigen become negative and quantitative analysis below the upper limit of test value
Time frame: 48 week, 96 week, 144 week
Plan to share: Yes — Individual participant data that underline the results reported in this article (text, tables, figures and appendices) will be shared.
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
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Third Affiliated Hospital, Sun Yat-Sen University