Entecavir to TAF Switch

Phase 3

Active, not recruiting

• Conditions: Hepatitis B
• Interventions: Drug: Tenofovir Alafenamide

• Registration Number: NCT03489239
• Lead Sponsor: Thomas Jefferson University

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-16
• Study First Submitted: 2018-03-14
• Study First Submitted QC: 2018-04-03
• Study First Posted: 2018-04-05
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-23
• Last Update Posted: 2020-06-25
• Primary Completion: 2020-08-15
• Study Completion: 2020-09-16

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 27

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm	Tenofovir Alafenamide	SingleArm: TAF 25 mg

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Improved Bone Mass Density at study completion	96 weeks	% change from baseline in BMD at the hip and lumbar spine at Week 96.
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

Trial Locations

Locations (1)

Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States