Entecavir to TAF Switch

Long-term Study to Observe Safety and Efficacy of TAF in Patients With Chronic Hepatitis B

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03489239

Enrollment

Registered

2018-04-05

Start date

2017-11-16

Completion date

2020-09-16

Last updated

2020-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis B

Brief 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

Interventions

DRUGTenofovir Alafenamide

subjects switching from Entecavir to single arm TAF 25mg

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Results of viral Hepatitis B DNA to be <20 IU/mL	48 weeks	The proportion of subjects with plasma HBV DNA levels below 20 IU/mL at week 48.

Secondary

Measure	Time frame	Description
Complete viral suppression at study completion	96 Weeks	The proportion of subjects with complete viral suppression, i.e., plasma HBV DNA level below 20 IU/mL at Week 96.
Positive eGFR changes at study completion compared to Baseline visit	96 weeks	Change in eGFR from baseline to Week 96
Improved Bone Mass Density at study completion	96 weeks	% change from baseline in BMD at the hip and lumbar spine at Week 96.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026