Trial intelligence / Profile preview

GS-4774 in virally-suppressed chronic hepatitis B

NCT01943799Phase 2

Key facts

Status: Completed
Start: Sep 2013
Primary completion: Sep 2014
Countries: 2
Sponsor: Gilead Sciences
Modality: Viral Vector Vaccines, Therapeutic Vaccines

Drugs: GS-4774
Conditions: Chronic Hepatitis B (CHB)

Overview

Phase 2, randomised, open-label trial of GS-4774 in Chronic Hepatitis B (CHB) (4 arms), sponsored by Gilead Sciences. Primary endpoint: Change From Baseline in HBsAg at 24 weeks. Started Sep 2013; status: completed.

Design

4 arms

Study design: RandomizedOpen-label

OAV Alone
OAV Regimen alone from baseline to Week 48
OAV + GS-4774 2 YU
OAV + GS-4774 2 YU (Wk 0-20)
OAV + GS-4774 10 YU
OAV + GS-4774 10 YU (Wk 0-20)
OAV + GS-4774 40 YU
OAV + GS-4774 40 YU (Wk 0-20)

Endpoints

Primary

Change From Baseline in HBsAg24 weeks

Secondary

Change From Baseline in HBsAg48 weeks
Percentage of Participants With HBsAg Loss and HBsAg Seroconversion48 weeks
Percentage of Participants With HBeAg Loss and HBeAg Seroconversion48 weeks
Percentage of Participants With a 1-log Decline in HBsAg48 weeks

Results

Not all primary endpoints met

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