NCT02174276

Safety and Efficacy of GS-4774 in Combination With Tenofovir Disoproxil Fumarate (TDF) for the Treatment of Participants With Chronic Hepatitis B (CHB) and Who Are Currently Not on Treatment

A Phase 2, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of GS-4774 in Combination With Tenofovir Disoproxil Fumarate (TDF) for the Treatment of Subjects With Chronic Hepatitis B and Who Are Currently Not on Treatment

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 195 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objectives of this study are to evaluate the safety, tolerability, and efficacy of GS-4774 in adults with CHB and who are currently not on treatment. Participants will be randomized to receive TDF alone or GS-4774 plus TDF for 20 weeks. After Week 20, GS-4774 will be discontinued. All participants will continue on TDF and will be followed for an additional 28 weeks. Following completion of the 48 week study period, all participants will be eligible for a treatment extension for 96 weeks.

Conditions

• Chronic Hepatitis B

Interventions

Type	Name	Description
DRUG	Tenofovir disoproxil fumarate	TDF 300 mg tablet administered orally once daily
BIOLOGICAL	GS-4774	GS-4774 subcutaneous injection administered every 4 weeks for a total of 6 doses

Timeline

• Start date: 2014-07-24
• Primary completion: 2016-02-17
• Completion: 2018-05-30
• First posted: 2014-06-25
• Last updated: 2019-06-04
• Results posted: 2019-06-04

Locations

33 sites across 6 countries: United States, Canada, Italy, New Zealand, Romania, South Korea

Regulatory

• FDA-regulated drug study