Entecavir to TAF Switch

Phase 3Active Not RecruitingNCT03489239

Thomas Jefferson University27 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Hepatitis B

Interventions

Tenofovir AlafenamideDRUG

subjects switching from Entecavir to single arm TAF 25mg

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

Results of viral Hepatitis B DNA to be <20 IU/mL

The proportion of subjects with plasma HBV DNA levels below 20 IU/mL at week 48.

Time frame: 48 weeks

Secondary Outcomes

Complete viral suppression at study completion

The proportion of subjects with complete viral suppression, i.e., plasma HBV DNA level below 20 IU/mL at Week 96.

Time frame: 96 Weeks

Positive eGFR changes at study completion compared to Baseline visit

Change in eGFR from baseline to Week 96

Time frame: 96 weeks

Improved Bone Mass Density at study completion

% change from baseline in BMD at the hip and lumbar spine at Week 96.

Time frame: 96 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.