NCT06000657

Efficacy and Safety of Switching to Vemliver From Entecavir in Chronic Hepatitis B Patients Previously Treated With Entecavir

Efficacy and Safety of Switching to Vemliver (Tenofovir Alafenamide) From Entecavir in Chronic Hepatitis B: A Multi-Center, Phase IV, Open-Label, Randomized, Active-Controlled, Non-Inferiority Trial.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 196 (actual)
• Sponsor: Daewoong Pharmaceutical Co. LTD. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Hepatitis B, Chronic

Interventions

Type	Name	Description
DRUG	Vemliver tablet	Chronic Hepatitis B Patients Who Pretreated with Entecavir switching to Vemliver tab (Tenofovir Alafenamide Hemitartrate)
DRUG	Baracross Tablet	Chronic Hepatitis B Patients Who Pretreated with Entecavir continuting treatement with Baracross Tablet

Timeline

• Start date: 2023-08-28
• Primary completion: 2025-02-03
• Completion: 2025-02-03
• First posted: 2023-08-21
• Last updated: 2025-03-18

Locations

1 site across 1 country: South Korea