Roll-over After 3-year Trial for Tenofovir in Mild Chronic Hepatitis B
Status:
Unknown status
Trial end date:
2020-01-01
Target enrollment:
Participant gender:
Summary
This open-label study is an roll-over extension of a randomized trial "Efficacy of Tenofovir
Disoproxil Fumarate in Chronic Hepatitis B Patients with High Viral Load but Slight
Aminotransferase Elevation" (NCT01522625).
After finishing the 3-year therapeutic trial, all patients receive open-label TDF for another
3 years. All patients undergo liver biopsy to evaluate the stage of fibrosis after the 3-year
open-label therapy. During the 3-year period, patients were followed up every 12 weeks for
the biochemical, serological, virological parameters, and adverse reactions.
The primary outcome is the progression of liver fibrosis. Safety issues such as change of
renal function and bone mineral density are 2nd outcomes.