drugset / Trial / NCT02371408
A Study of the Efficacy and Safety of PPI-668 (NS5A Inhibitor) Plus Sofosbuvir, With or Without Ribavirin, in Patients With Chronic Hepatitis C Genotype-4
RandomizedParallel-groupOpen-labelTreatment
Summary
The study will assess the efficacy of PPI-668 (USAN: ravidasvir hydrochloride) in combination with sofosbuvir, with or without ribavirin, in the following Egyptian HCV gt-4 patient populations: 1. Treatment-naïve patients, with and without cirrhosis (Group 1) 2. Previous non-responders to interferon-based therapies, without cirrhosis (Group 2) 3. Previous non-responders to interferon-based therapies, with cirrhosis (Group 3)
Timeline
- Start
- 2015-01
- Primary completion
- 2016-01
- Completion
- 2016-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ravidasvir | Small molecule | 200 mg | Oral |
| Subject | Ribavirin | Small molecule | 1000 mg | — |
| Subject | Ribavirin | Small molecule | 1200 mg | — |
| Subject | Sofosbuvir | Small molecule | 400 mg | Oral |