Treatment Outcomes in Chronic Hepatitis B Patients on Sequential Therapy With Tenofovir Alafenamide (TAF)

Phase 4

• Conditions: Chronic hepatitis B

• Registration Number: JPRN-UMIN000031832
• Lead Sponsor: Stanford University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-03-22
• Study Completion: 2021-09-07
• Last Update Posted: 20 November 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 270

Inclusion Criteria

Not provided

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 (below 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement and/or Persistence of Viral Suppresion [ Time Frame: 24 months ] To describe rate of persistence and/or improvement of viral suppression with TAF as with previous anti-HBV treatment

Secondary Outcome Measures

Name	Time	Method
ALT Normalization and/or Improvement [ Time Frame: 24 months ] To describe persistence of ALT normalization and/or improvement of ALT levels with TAF as with previous anti-HBV treatment Creatinine Clearance Trends [ Time Frame: 24 months ] To describe trends in calculated creatinine clearance as available by local labs. Serum Creatinine Trends [ Time Frame: 24 months ] To describe trends in serum creatinine as available by local labs. Bone Mass Density Trends [ Time Frame: 24 months ] To describe trends in bone mass density from baseline to end of study.