Entecavir to TAF Switch



Status:Recruiting
Conditions:Hepatitis, Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:9/13/2018
Start Date:November 16, 2017
End Date:November 16, 2019
Contact:Hie-Won Hann, MD
Email:hie-won.hann@jefferson.edu
Phone:215-955-5806

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

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


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.
We found this trial at
1
site
1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Principal Investigator: Hie-Won Hann, MD
Phone: 215-955-5806
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
2375
mi
from 91732
Philadelphia, PA
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