NCT03615066

Study to Evaluate the Safety, Tolerability, and Antiviral Activity of Selgantolimod (Formerly GS-9688) in Viremic Adult Participants With Chronic Hepatitis B (CHB) Who Are Not Currently on Treatment

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-center Study to Evaluate the Safety, Tolerability and Antiviral Activity of GS-9688 in Viremic Adult Subjects With Chronic Hepatitis B Who Are Not Currently on Treatment

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 67 (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 tolerability of multiple oral doses of selgantolimod and to evaluate the antiviral activity of selgantolimod in adult participants with chronic hepatitis B (CHB) who are viremic and not currently being treated.

Conditions

• Chronic Hepatitis B

Interventions

Type	Name	Description
DRUG	Placebo	Tablet(s) administered orally every 7 days for 24 doses in fasted state
DRUG	Selgantolimod	Tablet(s) administered orally every 7 days for 24 doses in fasted state
DRUG	TAF	Tablet(s) administered orally once daily with food

Timeline

• Start date: 2018-08-28
• Primary completion: 2019-12-12
• Completion: 2021-04-12
• First posted: 2018-08-03
• Last updated: 2022-05-10
• Results posted: 2021-01-06

Locations

10 sites across 3 countries: Canada, South Korea, Taiwan

Regulatory

• FDA-regulated drug study