Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510630, China
Location status: Recruiting
NCT Number: NCT04231565
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.
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Not applicable
Guangzhou, Guangdong, 510630, China
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients would receive treatment of oral Tenofovir alafenamide Fumarate(TAF)once per day.
Other names: Vemlidy
Time frame: 48 week, 96 week, 144 week
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 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 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 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 become negative and quantitative analysis below the upper limit of test value
Contact information is provided by the study sponsor or research team.
Liang Peng, Doctor
CONTACT
Qiumin Luo, Doctor
CONTACT
Third Affiliated Hospital, Sun Yat-Sen University
Other
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
Acronym: ALTHBV
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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