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

The primary objectives of this study are to evaluate the safety and tolerability of the 12 week treatment regimens of inarigivir (GS-9992) 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 plus TAF versus TAF alone in viremic CHB participants (Groups 1-3, 5), and to evaluate the antiviral activity of 12 weeks of inarigivir with commercially available NUC(s) in virally suppressed CHB participants (Group 4).


Study Type: Interventional  (Clinical Trial)
Estimated Enrollment: 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date: February 28, 2018
Estimated Primary Completion Date: April 2020
Estimated Study Completion Date: May 2021

Arms:
- Experimental: Group 1 (Inarigivir 50 mg + TAF)
- Experimental: Group 2 (TAF)
- Experimental: Group 3 (Inarigivir 200 mg + TAF)
- Experimental: Group 4 (Inarigivir 100 mg)
- Experimental: Group 5 (Inarigivir 200 mg + TAF)