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

NCT01896609 | Unknown Phase 4 DMC

• 1 other identifier: HCV05012012
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Chronic hepatitis c; Egyptian population; Reiferon Retard; Ribavirin; Nitazoxanide; Bon one

Outcome Measures

Primary Outcomes (1)

• Early virological response

  Early Virological Response (EVR) achieved by undetected Hepatitis C Virus (HCV) RNA after 12 weeks ( 3 months after start of treatment)

  3 months after start of treatment

Secondary Outcomes (1)

• Sustained Virological Response ( SVR )

  3 months after end of treatmet ( Week 60)

Other Outcomes (1)

• Safety outcome

  During the period of study medications taking (up to 48 weeks)

Study Arms (3)

Arm 1 (Standard therpy)

EXPERIMENTAL

Arm 1 : subject randomized to this arm will be receiving the standard care therapy for 48 weeks: * Reiferon Retard® 160 µg /week subcutaneous injection. * Ribavirin in a dose of 13 mg/kg/day orally

Biological: Reiferon Retard in Arm 1; Drug: Ribavirin in Arm 1

Arm 2 ( Xerovirinc)

EXPERIMENTAL

Arm 2 : Subjects randomized to this arm will be receiving the following medications for 48 weeks; * Reiferon Retard® 160 µg /week subcutaneous injection * Ribavirin in a dose of 13 mg/kg/day orally * Xerovirinc® 500mg twice daily orally.

Biological: Reiferon Retard in Arm 1; Drug: Xerovirinc in Arm 2; Drug: Ribavirin in Arm 1

Arm 3 ( Bon one )

EXPERIMENTAL

Arm 3: Subjects randomized to this arm will be receiving the following medications for 48 weeks: * Bon-One ® 0.5 µg daily orally * Reiferon Retard® 160 µg /week subcutaneous injection * Ribavirin in a dose of 13 mg/kg/day orally * Xerovirinc® 500mg twice daily orally.

Biological: Reiferon Retard in Arm 1; Drug: Bon one in Arm 3; Drug: Xerovirinc in Arm 2; Drug: Ribavirin in Arm 1

Interventions

Reiferon Retard in Arm 1 BIOLOGICAL

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

Also known as: Pegylated interferon alfa-2a (Reiferon Retard 160 µg ®)

Arm 1 (Standard therpy); Arm 2 ( Xerovirinc); Arm 3 ( Bon one )

Bon one in Arm 3 DRUG

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

Arm 3 ( Bon one )

Xerovirinc in Arm 2 DRUG

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

Also known as: Nitazoxanide

Arm 2 ( Xerovirinc); Arm 3 ( Bon one )

Ribavirin in Arm 1 DRUG

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

Arm 1 (Standard therpy); Arm 2 ( Xerovirinc); Arm 3 ( Bon one )

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• The subject signs and dates a written informed consent form (ICF) prior to any study-related activities, including discontinuation of any prohibited medications.
• If the subject is male and sexually active, he is eligible to enter and participate in this study if his partner(s) meet the criteria outlined in 2a or if he or his partner(s) are using one of the methods of birth control outlined in 2b. If the subject is female, she is eligible to enter and participate in this study if she meets the following criteria:
• Non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is postmenopausal; for purposes of this study, postmenopausal is defined as 1 year without menses); or
• Childbearing potential, has a negative serum pregnancy test at screening.
• The subject is between the ages of 20 and 50, inclusive at the time of the screening visit.
• The subject is an ambulatory outpatient. Ambulatory is defined as not depending exclusively on a wheelchair for mobility. Nursing home subjects may be enrolled provided they are ambulatory. Subjects with spinal cord injuries resulting in paraplegia may not be enrolled.
• The subject is or has been diagnosed with Hepatitis C genotype 4.
• Subjects are treatment Naive
• Male or female subjects with BMI ≤ 35 .
• Compensated liver disease with all the following minimum hematological and biochemical criteria:
• Hemoglobin \> 12 g/dl for males, \>11 g/dl for females.
• White blood cell count (WBC) \> 3,000 /mm3 - Absolute Neutrophilic count (ANC above 1000)
• Platelets \> 80,000/mm3
• Prothrombin time less than 4 seconds above the upper limit of normal (ULN).
• Serum albumin \> 3.5mg/dl

You may not qualify if:

• Alpha Fetoprotein within normal range obtained during one year prior to entry in the study. Results above the upper limit of normal but less than 100 units require both of the following:
• Alpha Fetoprotein obtained within 3 months of entry.
• Abdominal Ultrasound within 3 months of entry that is negative for evidence of hepatocellular carcinoma.
• If Alpha Fetoprotein is above 100 units CT scan of the abdomen that is negative for evidence of hepatocellular carcinoma is required.
• Patients must be serum hepatitis B surface antigen (HBsAg) negative.
• Negative Antinuclear Antibodies (ANA) or titer of \< 1:160
• Serum positive for anti-HCV antibodies and HCV-RNA.
• Abdominal Ultrasound obtained within one year prior to entry in the study
• Electrocardiogram for men aged \> 40 years.
• Normal urine analysis.
• Normal fundus exam.
• Serum Schistosoma antibody test, if positive \> 1/80, a rectal biopsy is required. If rectal biopsy is positive to living Schistosomal eggs, treatment of Active Schistosomal disease is required one month prior to enrollment.
• The subject has been diagnosed with HBV or HCV of any genotype other than genotype 4 and /or HIV.
• Subjects are older than 50 years or younger than 20 years of age.
• Women who are pregnant or breast-feeding.

Sponsors & Collaborators

• MinaPharm Pharmaceuticals: lead

Study Sites (1)

Faculty of Medicine , Cairo University

Cairo, Cairo Governorate, Egypt

RECRUITING

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

peginterferon alfa-2a; nitazoxanide; Ribavirin

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Gamal Esmat, MD

  Cairo University

  PRINCIPAL INVESTIGATOR

• Rasha Ahmed, MD

  Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2013
• First Posted: July 11, 2013
• Study Start: June 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: June 1, 2015
• Last Updated: July 11, 2013

Record last verified: 2013-07

Locations

EG (1)