Safety and Efficacy of GS-4774 for the Treatment of Chronic Hepatitis B

NCT01943799 ↗

Phase 2 Completed 178 enrolled Gilead Sciences

RandomizedParallel-groupOpen-labelTreatment

Summary

The primary objectives of this study are to evaluate the safety and efficacy of GS-4774 in adults with chronic hepatitis B (CHB) viral infection who have been virally suppressed with an oral antiviral (OAV) medication.

Timeline

Start: 2013-09-13
Primary completion: 2014-09-09
Completion: 2015-03-03

Publications

Lok AS, Pan CQ, Han SH, Trinh HN, Fessel WJ, Rodell T, Massetto B, Lin L, Gaggar A, Subramanian GM, McHutchison JG, Ferrari C, Lee H, Gordon SC, Gane EJ. Randomized phase II study of GS-4774 as a therapeutic vaccine in virally suppressed patients with chronic hepatitis B. J Hepatol. 2016 Sep;65(3):509-16. doi: 10.1016/j.jhep.2016.05.016. Epub 2016 May 19.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	GS-4774	Vaccine	2 unknown	Subcutaneous
Subject	GS-4774	Vaccine	10 unknown	Subcutaneous
Subject	GS-4774	Vaccine	40 unknown	Subcutaneous
Background	Adefovir	Unknown	—	—
Background	Entecavir	Small molecule	—	—
Background	Lamivudine	Other / unclassified	—	—
Background	Telbivudine	Small molecule	—	—
Background	Tenofovir disoproxil fumarate	Small molecule	—	—

Safety and Efficacy of GS-4774 for the Treatment of Chronic Hepatitis B

Summary

Timeline

Publications

Drugs

Indications