Entecavir to TAF Switch

Thomas Jefferson University

Status and phase: Active, not recruiting; Phase 3

Conditions: Hepatitis B

Treatments: Drug: Tenofovir Alafenamide

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03489239

11729

Details and patient eligibility

About

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

Enrollment: 27 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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27 participants in 1 patient group

Single Arm

Experimental group

Description:

SingleArm: TAF 25 mg

Treatment:

Drug: Tenofovir Alafenamide