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

A Phase IIb/IIIa, Randomized Study to Evaluate the Efficacy and Safety of PPI-668 (NS5A Inhibitor) Plus Sofosbuvir, With or Without Ribavirin, in Patients With Chronic Hepatitis C Genotype-4

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Pharco Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Chronic Hepatitis C

Interventions

Type	Name	Description
DRUG	ravidasvir hydrochloride	200 mg
DRUG	sofosbuvir	400 mg
DRUG	ribavirin	1000 mg - 1200 mg per day, weight-based dosing

Timeline

• Start date: 2015-01-01
• Primary completion: 2016-01-01
• Completion: 2016-04-01
• First posted: 2015-02-25
• Last updated: 2016-04-07

Locations

3 sites across 1 country: Egypt