Trial intelligence / Profile preview

GSK548470 (Tenofovir Disoproxil Fumarate) in Chronic Hepatitis B

NCT01475851Phase 3

Key facts

Status: Completed
Start: Dec 2011
Primary completion: Jun 2013
Countries: 1
Sponsor: GSK
Modality: Small Molecules

Drugs: tenofovir disoproxil fumarate
Conditions: Chronic Hepatitis B (CHB)

Overview

Phase 3, open-label, single-arm trial of tenofovir disoproxil fumarate in Chronic Hepatitis B (CHB), sponsored by GSK. Primary endpoint: Number of Participants With HBV DNA Level < 2.1 log10 Copies/mL at Week 24. Started Dec 2011; status: completed.

Design

1 arm

Study design: Non-randomizedOpen-label

GSK548470 300 mg
Tenofovir disoproxil fumarate 300 mg once daily

Who it enrols

Japanese patients aged 16-69 with compensated chronic hepatitis B who have responded poorly to prior treatment with lamivudine/adefovir or entecavir.

Endpoints

Primary

Number of Participants With HBV DNA Level < 2.1 log10 Copies/mL at Week 2424 weeks

Secondary

Mean Change From Baseline in Serum HBV DNA Level96 weeks
Number of Participants With Serum HBV DNA < 2.1 log10 Copies/mL96 weeks
Number of Participants With Alanine Aminotransferase (ALT) Normalization96 weeks
Number of Participants With HBeAg Loss96 weeks
Number of Participants With HBeAg/HBeAb Seroconversion96 weeks
Number of Participants Achieving HBsAg Loss96 weeks
Number of Participants Achieving HBsAg/HBsAb Seroconversion96 weeks
Number of Participants With Virological Breakthrough and Resistance-related Mutations96 weeks

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