Utilization and Efficacy of Tenofovir DF in Adolescents With Chronic Hepatitis B Virus Infection
Status:
Terminated
Trial end date:
2018-04-11
Target enrollment:
Participant gender:
Summary
The primary objective of this study is to characterize the long term (ie, 96 weeks of follow
up) bone safety profile of open-label tenofovir disoproxil fumarate (tenofovir DF) treatment
in CHB-infected adolescents. This includes prospectively evaluating and comparing the bone
mineral density (BMD) change between CHB-infected adolescents 12 to < 18 years of age treated
with tenofovir DF in European treatment centers who are assigned to one of two schedules for
renal and bone laboratory monitoring and BMD measurement.