At a glance
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A Randomized, Double-Blind Evaluation of the Antiviral Efficacy, Safety, and Tolerability of Tenofovir Disoproxil Fumarate Versus Placebo in Pediatric Patients With Chronic Hepatitis B Infection
In Brief
A Phase 3 clinical trial evaluating Tenofovir DF and TDF Placebo for Chronic Hepatitis B. Active but no longer recruiting, targeting 90 participants across 21 sites in 5 countries.
Detailed Summary
The primary objective of this study is to evaluate the antiviral efficacy of tenofovir disoproxil fumarate (tenofovir DF; TDF) versus placebo in pediatric population (aged 2 to \< 12 years at the time of enrollment) with chronic hepatitis B (CHB) infection.
Study Details
Timeline
Interventions
* Participants weighing ≥ 17 kg will receive TDF one tablet administered orally once daily (150, 200, 250 or 300 mg tablets based on body weight). * Participants weighing \< 17 kg or ≥ 17 kg who are unable to swallow a tablet will receive TDF oral powder in a dose of 8 mg/kg once daily up to a maximum dose of 300 mg.
* Participants weighing ≥ 17 kg will receive TDF placebo tablet administered orally once daily. * Participants weighing \< 17 kg or ≥ 17 kg who are unable to swallow a tablet will receive TDF placebo oral powder once daily.