Effectiveness of TAF in Reducing Clinical Events in CHB Patients Beyond Treatment Indications by Current Guidelines

Summary

Participation Requirements

Description

Study objectives: To investigate whether TAF treatment reduce clinical events (HCC, death, liver decompensation, portal hypertensive complications, and liver transplantation) in CHB patients beyond treatment indications by current guidelines Study procedure: 780 subjects will be randomized in a 1:1 ...

Study objectives: To investigate whether TAF treatment reduce clinical events (HCC, death, liver decompensation, portal hypertensive complications, and liver transplantation) in CHB patients beyond treatment indications by current guidelines Study procedure: 780 subjects will be randomized in a 1:1 ratio (A:B) either to receive TAF 25 mg QD or to receive best supportive care after stratification according to the HBeAg status. The duration of maintaining both arms is 4 years. During treatment period, among treatment arm B, subjects who are indicated for antiviral treatment by AASLD 2018 Guidelines of CHB (ALT 70? for male, 50? for female) will be treated with TAF. Treatment Arm A: 390 subjects administered TAF 25 mg once daily Treatment Arm B: 390 subjects received best supportive care The primary analysis will occur at Year 4 with the primary endpoint being cumulative incidence rate of clinical events

Tracking Information