The primary objectives of this study are as follows: Part A: To evaluate the steady state pharmacokinetics (PK) of tenofovir alafenamide (TAF) and confirm the dose of TAF 25 mg tablet given once daily in treatment-naive and treatment-experienced adolescents (aged 12 to < 18 years) with chronic hepatitis B (CHB) Part B: To evaluate the safety, tolerability, and antiviral activity (HBV DNA < 20 IU/mL) of TAF 25 mg once daily versus placebo through Week 24 in treatment-naive and treatment-experienced adolescents with CHB.
A Randomized, Double-Blind Evaluation of the Pharmacokinetics, Safety, and Antiviral Efficacy of Tenofovir Alafenamide (TAF) in Adolescents With Chronic Hepatitis B Virus Infection
Chronic Hepatitis BCHBHBVTenofovir
For people ages 12–17
Key Inclusion criteria:
Males and non-pregnant, non-lactating females
Weight at Screening: ≥ 35 kg (77 lbs)
Able to swallow oral tablets
Willing and able to provide written informed consent/assent (child and parent/legal guardian)
Documented evidence of CHB (eg, HBsAg-positive for ≥ 6 months)
Treatment-naive or treatment-experienced will be eligible for enrollment.