Hepatitis B, Chronic Clinical Trial
Official title:
The Efficacy and Safety of Switching to Vemliver Tab (Tenofovir Alafenamide Hemitartrate) From Entecavir in Chronic Hepatitis B Patients Who Pretreated With Entecavir; A Multi-Center, Randomized, Open-Label, Active-Controlled, Non-Inferiority, Phase IV Clinical Trial
Enroll patients who are pre-treated with Entecavir at least 24 weeks and confirmed HBV antiviral (HBV DNA <69 IU/mL) effects. Subjects are given one test drug or comparator once a day for 48 weeks according to the results of random assignments, and their HBV antiviral inhibitory effect and safety are evaluated at 24 and 48 weeks visits.
Enroll patients who are pre-treated with Entecavir at least 24 weeks and confirmed HBV antiviral (HBV DNA <69 IU/mL) effects. At the time of screening, potential test subjects of this test are selected by retrospectively collecting information on disease status and prognosis-related factors, including ETV administration information, among those who voluntarily agreed to participate in this clinical trial. HBeAg status (positive vs. positive) through Visit 1's Heptatis B Serology test before administering clinical trial drugs to test subjects who finally qualify for selection/exclusion criteria at the baseline. Voice) is set as a stratification factor and is randomly assigned to each test institution. Subjects are given one test drug or comparator once a day for 48 weeks according to the results of random assignments, and their HBV antiviral inhibitory effect and safety are evaluated at 24 and 48 weeks visits. ;
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