Clinical Trial

Study to Evaluate the Antiviral Efficacy, Safety and Tolerability of Tenofovir Disoproxil Fumarate Versus Placebo in Pediatric Participants With Chronic Hepatitis B Infection

Active, Not Recruiting Phase 3
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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.
Protocol Amendment History 48 amendments
This ClinicalTrials.gov record has been amended 48 times since 2012-07-25; most recent amendment 2026-01-14.
Status change: Recruiting → Active, Not Recruiting 2016-12-23
Status change: Not Yet Recruiting → Recruiting 2012-10-12
Trial Details
NCT Number NCT01651403
Lead Sponsor Gilead Sciences
Conditions Chronic Hepatitis B
Enrollment 90 participants
Start Date 2012-12-06
Primary Completion 2017-08-07 (estimated)
Study Completion 2027-07 (estimated)
Updated on ClinicalTrials.gov 2026-01-30