Hepatitis B Virus (HBV) Clinical Trial
Official title:
A Randomized, Double-Blind Evaluation of the Antiviral Efficacy, Safety, and Tolerability of Tenofovir Disoproxil Fumarate Versus Placebo in Adolescents With Chronic Hepatitis B Infection
The primary purpose of the study is to evaluate the effectiveness, safety, and tolerability
of tenofovir disoproxil fumarate (TDF) in adolescents (aged 12-17 years) with chronic
hepatitis B virus (HBV) infection.
The optimal treatment for adolescents with chronic HBV infection is currently unknown.
Treatment with interferon alfa, lamivudine, and adefovir dipivoxil in pediatric populations
has been shown to be less than optimal. Further, the safety and efficacy of entecavir and
telbivudine have not been established in patients < 16 years of age. A study evaluating TDF
in adolescents (ages 12-17) was needed to assess the safety and efficacy of this agent in
the treatment of chronic hepatitis B in this patient population. In addition, the study will
help to further elucidate the pharmacokinetic (PK) and resistance profiles of TDF. Through
their participation, study participants will help generate critical new information to help
guide the most optimal treatment of chronic HBV infection in adolescents.
This is a randomized, double-blind study to evaluate the antiviral efficacy, safety, and
tolerability of TDF versus placebo in adolescents with chronic HBV infection. One hundred
TDF treatment-naive participants were randomized in a 1:1 ratio to TDF or placebo. After 72
weeks of blinded treatment, all participants were to switch to open-label TDF for an
additional 2.5 years of treatment, provided that no safety concerns are identified by the
Independent Data Monitoring Committee monitoring the study.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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