NCT01943799

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

A Phase 2, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of GS-4774 for the Treatment of Virally-Suppressed Subjects With Chronic Hepatitis B

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 178 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic HBV Infection

Interventions

Type	Name	Description
BIOLOGICAL	GS-4774	Administered as a subcutaneous injection every 4 weeks for a total of 6 doses
DRUG	OAV Regimen	Administered prior to study enrollment (tenofovir disoproxil fumarate, entecavir, adefovir, lamivudine, or telbivudine either as single agents or in combination)

Timeline

• Start date: 2013-09-13
• Primary completion: 2014-09-09
• Completion: 2015-03-03
• First posted: 2013-09-17
• Last updated: 2019-11-01
• Results posted: 2019-11-01

Locations

17 sites across 2 countries: United States, New Zealand

Regulatory

• FDA-regulated drug study