©2022 Stanford Medicine
Treatment Outcomes in Chronic Hepatitis B Patients on Sequential Therapy With Tenofovir Alafenamide (TAF)
Not Recruiting
Trial ID: NCT03471624
Purpose
Primary Objective:
To describe rate of persistence and/or improvement of viral suppression with TAF as with
previous anti-HBV (hepatitis B virus) treatment
Official Title
Treatment Outcomes in Chronic Hepatitis B Patients on Sequential Therapy With Tenofovir Alafenamide (TAF)
Stanford Investigator(s)
Mindie H. Nguyen, MD, MAS, AGAF, FAASLD
Professor of Medicine (Gastroenterology and Hepatology) and, by courtesy, of Epidemiology and Population Health
Eligibility
Inclusion criteria:
1. Male or female, age ≥18 years
2. Chronic hepatitis B diagnosis confirmed by positive HBsAg or HBV DNA or HBeAg or
documented history of chronic hepatitis B in physician note
3. Currently maintained on antiviral therapy for at least 48 weeks with any Hepatitis B
virus(HBV) DNA value at Screening/Baseline and planned to be switched to TAF by their
physician
4. Routinely monitored for serum HBV DNA Polymerase chain reaction(PCR), liver chemistry
including Aspartate aminotransferase (AST )/alanine transaminase(ALT)/total bilirubin,
renal chemistry including Blood urea nitrogen(BUN)/Creatinine/Carbon dioxide (CO2) by
their physicians every 3-6 months and a bone density scan at least every 2 years as
per routine clinical care (one at baseline and one 2 years after switch).
5. Estimated creatinine clearance > 15 ml/min (using the Cockcroft-Gault method) at
Screening/Baseline Visit. (Note: multiply estimated rate by 0.85 for women).
6. Willing and able to provide informed consent
7. Able to comply with dosing instructions for study drug administration and able to
complete the study schedule of assessments
Exclusion criteria:
1. Pregnant women, women who are breastfeeding or who believe they may wish to become
pregnant during the course of the study
2. Previous recipient of a liver transplant
3. Co-infection with human immunodeficiency virus (HIV) or hepatitis C (HCV) or hepatitis
D (HDV)
4. Severe or uncontrolled comorbidities
5. Current or known hepatic decompensation (≤2 years) (e.g ascites, encephalopathy, or
variceal hemorrhage) with a Child-Pugh score of B or C
6. Malignancy including liver cancer within 5 years except cancers curable by surgical
resection (e.g. basal cell skin cancer and squamous cell cancer)
7. On any of the disallowed concomitant medications listed in the prior and concomitant
medications list (pg. 11). Subjects on prohibited medications who are otherwise
eligible will need a wash out period of at least 30 days prior to the
Screening/Baseline visit.
8. Males and females of reproductive potential who are unwilling to use "effective"
protocol-specified method(s) of contraception during the study.
9. Current substance or alcohol abuse judged by the investigator to potentially interfere
with subject compliance.
10. Any other clinical conditions that, in the opinion of the Investigator, would make the
subject unsuitable or unable to comply with any of the study procedures
Intervention(s):
drug: Tenofovir Alafenamide
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Mindie H Nguyen, MD,MAS
650-736-1731