NCT03753074

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

A Multinational, Multicenter, Open-label, Randomized Controlled Trial to Investigate the Effectiveness of Tenofovir Alafenamide in Reducing Clinical Events in Chronic Hepatitis B Patients Beyond Treatment Indications by Current Guidelines

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 780 (estimated)
• Sponsor: Young-Suk Lim · Academic / Other
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Treatment with Tenofovir Alafenamide(TAF) in Chronic Hepatitis B (CHB) patients classified as beyond treatment indication of current international guidelines (e.g. aged more than 40 years old and 4 ≤ log HBV-DNA IU/mL \< 8) is expected to bring improvement in long-term clinical outcomes. This expected result may expand the treatment indications in patients with CHB based on age and HBV-DNA in contrast to current international guidelines of CHB.

Detailed 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 ratio (A:B) either to receive TAF 25 mg QD or to receive best supportive care after stratification according to the HBeAg status. The study duration is 12 years. During treatment period, among treatment arm B, subjects who are indicated for antiviral treatment will be treated with TAF as follows: 1. Based on the AASLD 2018 Guidelines of CHB (ALT 70≥ for male, 50≥ for female) 2. 40≤ALT levels\<70 IU/L (males) or 40≤ ALT levels\<50 IU/L (females) with evidence of significant fibrosis(F2; ≥7.2 kPa) as measured by either liver biopsy, Fibroscan or MR elastograpy performed within 3 months. 3. If they were clinically judged to have cirrhosis by investigators and confirmed with Fibroscan (≥ 12.0 kPa). * 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 occurrence of composite events during follow-up observation

Conditions

• Chronic Hepatitis b

Interventions

Type	Name	Description
DRUG	Tenofovir Alafenamide	Tenofovir Alafenamide 25mg, Tablet, Oral, Daily

Timeline

• Start date: 2019-02-18
• Primary completion: 2031-12-31
• Completion: 2031-12-31
• First posted: 2018-11-26
• Last updated: 2024-12-17

Locations

10 sites across 1 country: South Korea