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

Chronic Hepatitis c Clinical Trial

Official title: A Single Center, Prospective Phase IV, Open-Label, Randomized Trial Comparing the Efficacy , Tolerability, and Safety of Quadritherapy Regimen (Reiferon Retard® + Ribavirin + Nitazoxanide + Alfacalcidol ( Bon-One ®) ) Versus Triple Therapy Regimen (Reiferon Retard® + Ribavirin + Nitazoxanide) Versus the Standard of Care Regimen(Reiferon Retard® + Ribavirin) in the Treatment of Naïve Chronic Hepatitis- C Among the Egyptian Population. Effectiveness Will be Evaluated Based on Sustained Viral Response (SVR)

Status Recruiting

Clinical Trial 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 .

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis c
• Hepatitis
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

• NCT number: NCT01896609
• Study type: Interventional
• Source: MinaPharm Pharmaceuticals
• Status: Recruiting
• Phase: Phase 4
• Start date: June 2013
• Completion date: June 2015