Tenofovir Alafenamide (TAF) in Children and Adolescents With Chronic Hepatitis B Virus Infection
Status:
Recruiting
Trial end date:
2029-10-01
Target enrollment:
Participant gender:
Summary
The primary objective of Cohort 1 of this study is to evaluate the safety, tolerability, and
antiviral activity (HBV DNA < 20 IU/mL) of tenofovir alafenamide (TAF) 25 mg once daily
versus placebo through Week 24 in treatment-naive and treatment-experienced adolescents (aged
12 to < 18 years) with chronic hepatitis B (CHB).
Cohort 2 will consist of 2 parts: Part A and Part B. Intensive pharmacokinetic (PK) data will
be collected from all participants in Part A to confirm the dose of TAF in each dose group
and the remaining participants will be enrolled into Part B once dose confirmation is
achieved. The primary objectives of Part A are to evaluate the steady-state PK of TAF and
tenofovir (TFV) and confirm the dose of TAF given once daily in children (aged 2 to < 12
years) with CHB. The primary objective of Part B is to evaluate the safety and tolerability
of TAF at Week 48 and the antiviral activity (HBV DNA < 20 IU/mL) of TAF at Week 24 in
children (aged 2 to < 12 years) with CHB.