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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 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2016-04-07

No results posted yet for this study

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

DRUG

ravidasvir hydrochloride

200 mg

DRUG

sofosbuvir

400 mg

DRUG

ribavirin

1000 mg - 1200 mg per day, weight-based dosing

Sponsors & Collaborators

  • Pharco Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Gamal Esmat, M.D. · Kasr El Aini Viral Hepatitis Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2016-01-31
Completion
2016-04-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02371408 on ClinicalTrials.gov