drugset / Trial / NCT03186313

A Study to Evaluate the Safety and Efficacy of the Combined Single Dose of Dactavira Plus Or Dactavira in Egyptian Adults With Chronic Genotype 4 HCV Infection

NCT03186313

RandomizedParallel-groupOpen-labelTreatment

Summary

A phase 3 Randomized, Open-Label, Study to Evaluate the Safety and Efficacy of the combined single dose of Dactavira Plus (EPGCG, Sofosbuvir , Daclatasvir \& Ribavirin) versus Sofosbuvir + Daclatasvir + Ribavirin (Part A) and a single dose of Dactavira (EPGCG, Sofosbuvir \& Daclatasvir) versus Sofosbuvir + Daclatasvir (Part B) in Egyptian Adults with Chronic Genotype 4 HCV Infection.

Timeline

Start
2016-09
Primary completion
2017-05
Completion
2017-11-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Daclatasvir Small molecule 60 mg
Subject Dactavira Unknown
Subject Dactavira Plus Unknown
Comparator Ribavirin Small molecule 800 mg
Comparator Sofosbuvir Small molecule 400 mg