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 .

Conditions

• Chronic Hepatitis c

Interventions

BIOLOGICAL

Reiferon Retard in Arm 1

Arm 1,2,3 Reiferon Retard® 160 µg /week subcutaneous injection for 48 weeks

DRUG

Bon one in Arm 3

Arm 3 , Bon One ® 0.5 µg daily orally for 48 weeks

DRUG

Xerovirinc in Arm 2

Arm 2,3 Xerovirinc® 500mg twice daily orally for 48 weeks

DRUG

Ribavirin in Arm 1

Arm 1,2,3 Ribavirin in a dose of 13 mg/kg/day orally for 48 weeks

Sponsors & Collaborators

• MinaPharm Pharmaceuticals

  lead INDUSTRY

Principal Investigators

• Gamal Esmat, MD · Cairo University

• Rasha Ahmed, MD · Cairo University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

50 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-06-30

Primary Completion

2015-01-31

Completion

2015-06-30

Countries

• Egypt

Study Locations