Trial intelligence / Profile preview

Tenofovir Disoproxil Fumarate vs Placebo in Pediatric Chronic Hepatitis B

2024-517526-26-00Phase 3Completed

Sponsor
Gilead Sciences
Start
Nov 2024
Modality
Small Molecules
Countries
5
01

Overview

Phase 3, randomised, double-blind trial in hepatitis B (HBV) comparing Viread with Placebo (2 arms). Primary endpoints: Percentage of participants with serum HBV DNA < 400 copies/mL (69 IU/mL) at Week 48 (missing = failure approach) and Percentage of participants with serum HBV DNA < 400 copies/mL (69 IU/mL) at Week 48 (missing = excluded approach). Started Nov 2024; status: completed.

02

Drugs

tenofovir disoproxil fumarate
03

Conditions

hepatitis B (HBV)

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