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

NCT02371408

Phase 2/3 Unknown 300 enrolled Pharco Pharmaceuticals
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

EvaluationDrugModalityDoseRoute
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