drugset
drugset / Trial / NCT01651403

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

NCT01651403 ↗

Phase 3 Active not recruiting 90 enrolled Gilead Sciences
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2012-12-06
Primary completion
2017-08-07
Completion
2027-07

Publications

  • Results (Oral Presentation) Mei-Hwei Chang, Jae Hong Park, Jorge A. Bezerra, Daniela Pacura, Sandeep Nijhawan, Byung-Ho Choe, et al. Randomized, Double-Blind, Placebo-Controlled Trial of Tenofovir Disoproxil Fumarate (TDF) in Children with Chronic Hepatitis B (CHB). Hepatology, 2018; 68 (Suppl 1): 49A.

Drugs

EvaluationDrugModalityDoseRoute
Subject Tenofovir disoproxil fumarate Small molecule 8 mg/kg Oral
Subject Tenofovir disoproxil fumarate Small molecule 150 mg Oral
Subject Tenofovir disoproxil fumarate Small molecule 200 mg Oral
Subject Tenofovir disoproxil fumarate Small molecule 250 mg Oral
Subject Tenofovir disoproxil fumarate Small molecule 300 mg Oral

Indications

chronic hepatitis B virus infection