drugset / Trial / 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)
RandomizedParallel-groupOpen-labelTreatment
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).
Timeline
- Start
- 2018-02-28
- Primary completion
- 2020-01-20
- Completion
- 2021-01-26
Publications
- Results Lim YS, Hui AJ, Jang JW, Tak WY, Ahn SH, Jang BK, et al. Safety, efficacy, & pharmacodynamic (PD) activity of 12 weeks treatment with oral RIG-I agonist, inarigivir (IRIG), plus 48 weeks of tenofovir alafenamide in adult patients with chronic hepatitis B: a phase 2 collaboration study [Abstract PO-2422]. The International Liver Congress: European Association for the Study of the Liver (EASL) Virtual; 2021 23-26 June.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Inarigivir soproxil | Small molecule | 50 mg | Oral |
| Subject | Inarigivir soproxil | Small molecule | 100 mg | Oral |
| Subject | Inarigivir soproxil | Small molecule | 200 mg | Oral |
| Subject | Inarigivir soproxil | Small molecule | 400 mg | Oral |
| Subject | TAF | Unknown | 25 mg | Oral |