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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
30
300 mg tablet administered orally once daily for up to 96 weeks
Dual energy x-ray absorptiometry (DEXA) scans administered at protocol-specified time points
Cliniques Universitaries Saint- Luc, Departem Pediatrie
Brussels, Belgium
Hopital Femmes Meres Enfants
Bron, France
Attikon General Hospital Of Athens
Chaïdári, Greece
Percentage of Participants With Bone-Related Adverse Events and/or a ≥ 4% Reduction in Bone Mineral Density (BMD) From Baseline to Week 96
Time frame: Baseline to Week 96
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Azienda Ospedaliero-Universitaria di Bologna
Bologna, Italy
Grigore Alexandrescu Childrens Emergency Clinical Hospital
Bucharest, Romania
Spitatul Clinic de Boli Infectioase Constanta
Constanța, Romania
Institutul de Gastrenterologie si Hepatologie Iasi
Iași, Romania
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain
Hospital Sant Joan de Déu
Barcelona, Spain
Hospital de Meixoeiro
Vigo, Spain
...and 1 more locations