Trial Comparing the Efficacy, Tolerability and Safety Between Three Arms in Treatment of HCV in Egyptian Population

Summary

A single Center, Prospective Phase IV, Open-Label, Controlled, Randomized Trial comparing the efficacy, safety, and tolerability of Quadritherapy regimen (Reiferon Retard® , Ribavirin , Nitazoxanide and Alfacalcidol (Bon-One ® ) versus Triple therapy regimen (Reiferon Retard® , Ribavirin and Nitazoxanide) versus the standard of care regimen(Reiferon Retard® and Ribavirin) in the treatment of Naïve chronic hepatitis C among the Egyptian population. Effectiveness will be evaluated based on Sustained Virological Response (SVR) . PRIMARY OBJECTIVE(S): The primary objectives of this trial are as follows: * To compare the efficacy of the three treatment arms in naïve Chronic Hepatitis C Virus (HCV) genotype 4 patients by evaluating the sustained virological response ( SVR) at week 60 ( 3 months after end of treatment period) * Identify optimum treatment protocol for HCV genotype 4 in respect to used combination of medications * Whether adding vitamin D, a potent immunomodulator, could improve viral response. STUDY DESIGN: This is a phase IV, single center, open labeled, randomized (1:1:1) controlled study. NUMBER OF EVALUABLE SUBJECTS: 300 NUMBER OF CENTER/S: 1 Country:Egypt DURATION OF THE STUDY: 94 weeks TREATMENT: randomized 1:1:1 ratio into 3 Arms SUBJECT POPULATION: male or female subjects assessed by BMI less than 35, between the ages of 20 and 50 years. Subjects have to be diagnosed as Naïve Chronic Hepatitis C genotype 4 patients with compensated liver disease assessed by hematological and biochemical tests. \- DURATION OF THE STUDY: 94 weeks as follows: Estimated Enrollment Duration: 16 weeks Collection of last Case Report Form (CRF) : 2 weeks from Last patient out. Queries Resolution: 4 weeks from Collection of last CRF. Database lock planned date: 2 weeks from Quires resolution. Final Study Report: 8 weeks from Database lock. Estimated duration of subject participation: 62 weeks as follows; * Screening period per subject = 2 weeks * Treatment phase per subject = 48 weeks * Follow-up phase per subject = 12 weeks N.B : Each patient will receive medications for Maximum 48 weeks if his/her Polymerase Chain Reaction (PCR) -ve at weeks 12 and 24 , and if his/her PCR +ve at week 12 or week 24 the treatment will be stopped .

Timeline

Start

2013-06

Primary completion

2015-01

Completion

2015-06

Drugs

Indications