drugset / Trial / NCT02993250
A Study to Investigate the Safety, Pharmacokinetics, and Efficacy of Combination Treatment of AL-335, Odalasvir, and Simeprevir in Japanese Participants With Chronic Hepatitis C Genotype 1 or 2 Virus Infection, With or Without Compensated Cirrhosis Who Are Direct Acting Antiviral Treatment-naive
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The main purpose of this study is to evaluate the safety and tolerability of a combination treatment of AL-335, odalasvir (ODV), and simeprevir (SMV) for 8 weeks in Japanese participants with genotype 1 or 2 chronic hepatitis C virus (HCV) infection without cirrhosis and for 12 weeks in direct-acting antiviral (DAA)-naive Japanese participants with genotype 1 or 2 chronic HCV infection with compensated cirrhosis.
Timeline
- Start
- 2016-12-21
- Primary completion
- 2018-05-07
- Completion
- 2018-05-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ADAFOSBUVIR | Small molecule | 800 mg | — |
| Subject | Odalasvir | Small molecule | 25 mg | — |
| Subject | Simeprevir | Small molecule | 75 mg | — |