Entecavir to TAF Switch

• Status: Active, not recruiting
• Trial end date: 2020-09-16
• Target enrollment: 0
• Participant gender: All

Summary

A research study to observe the safety, efficacy and tolerability of switching from Entecavir (ETV) to Tenofovir Alafenamide TAF in patients with chronic hepatitis B

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Thomas Jefferson University
• Collaborator: Gilead Sciences
• Treatments: Entecavir; Tenofovir

Criteria

Inclusion Criteria:

• Subjects, adult male and female ≥18 years of age with chronic hepatitis B with or without compensated cirrhosis

• Maintained on Entecavir for a minimum of 48 weeks

• Viral suppression (HBV DNA <20 IU/mL) for a minimum of 12 weeks prior to entry are eligible for this study.

• Estimated creatinine clearance ≥ 50 ml/min (using the Cockcroft-Gault method) based on serum creatinine and actual body weight as measured at the baseline evaluation.

Exclusion Criteria:

• Subjects with known poor or non-compliance

• Subjects with co-infection with HCV or HIV subjects with decompensated cirrhosis and HCC will be excluded to participate in the study.

• Pregnant women and those who wish to become pregnant during the course of the study.