NCT03434353

Study to Evaluate the Safety and Antiviral Activity of Inarigivir Soproxil (Formerly: GS-9992) Plus Tenofovir Alafenamide (TAF) for 12 Weeks in Adults With Chronic Hepatitis B (CHB)

A Phase 2, Randomized, Open-Label, Active-Controlled Study to Evaluate the Safety and Antiviral Activity of GS-9992 Plus Tenofovir Alafenamide (TAF) for 12 Weeks in Chronic Hepatitis B (CHB) Subjects

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 123 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The primary objectives of this study are to evaluate the safety and tolerability of the 12 week treatment regimens of inarigivir soproxil plus tenofovir alafenamide (TAF) or commercially available nucleoside/nucleotide (NUC) in adults with chronic hepatitis B (CHB), to evaluate the antiviral activity of 12 weeks of inarigivir soproxil plus TAF versus TAF alone in viremic CHB participants (Groups 1-3, 5), and to evaluate the antiviral activity of 12 weeks of inarigivir soproxil with commercially available NUC(s) in virally suppressed CHB participants (Group 4).

Conditions

• Chronic Hepatitis B

Interventions

Type	Name	Description
DRUG	Inarigivir Soproxil	Administered orally once daily one hour before or one hour after a meal
DRUG	TAF	Administered orally once daily with food

Timeline

• Start date: 2018-02-28
• Primary completion: 2020-01-20
• Completion: 2021-01-26
• First posted: 2018-02-15
• Last updated: 2022-04-04
• Results posted: 2022-04-04

Locations

13 sites across 2 countries: Hong Kong, South Korea

Regulatory

• FDA-regulated drug study