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 |
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
(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
Philadelphia, Pennsylvania 19107
(215) 955-6000
Principal Investigator: Hie-Won Hann, MD
Phone: 215-955-5806
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