Entecavir to TAF Switch

Running, not enrolling · Phase 3

Conditions studied: Hepatitis B

In brief

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

Key facts

Study ID

NCT03489239

Run by

Thomas Jefferson University

People needed

27

Starts

2017-11-16

Expected to finish

2020-09-16

Last updated by the study team

2020-06-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Thomas Jefferson University — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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