NCT02579382

Study to Evaluate the Safety, Tolerability, and Efficacy of Vesatolimod in Combination With Tenofovir Disoproxil Fumarate (TDF) in Adults With Chronic Hepatitis B (CHB) Infection Who Are Currently Not Being Treated

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-center Study to Evaluate the Safety and Efficacy of GS-9620 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: 192 (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, tolerability, and efficacy of vesatolimod (formerly GS-9620) in adults with chronic hepatitis B (CHB) infection who are currently not being treated.

Conditions

• Chronic Hepatitis B

Interventions

Type	Name	Description
DRUG	TDF	300 mg tablets administered orally once daily
DRUG	Vesatolimod	Tablets administered orally once a week (every 7 days) for 12 doses
DRUG	Placebo	Placebo administered orally once a week (every 7 days) for 12 doses

Timeline

• Start date: 2015-11-10
• Primary completion: 2017-01-16
• Completion: 2019-05-03
• First posted: 2015-10-19
• Last updated: 2020-05-18
• Results posted: 2020-05-18

Locations

21 sites across 8 countries: United States, Canada, Hong Kong, Italy, New Zealand, South Korea, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study