Chronic Hepatitis c
Conditions
Keywords
Chronic hepatitis c, Egyptian population, Reiferon Retard, Ribavirin, Nitazoxanide, Bon one
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 .
Interventions
BIOLOGICALReiferon Retard in Arm 1
Arm 1,2,3 Reiferon Retard® 160 µg /week subcutaneous injection for 48 weeks
DRUGBon one in Arm 3
Arm 3 , Bon One ® 0.5 µg daily orally for 48 weeks
DRUGXerovirinc in Arm 2
Arm 2,3 Xerovirinc® 500mg twice daily orally for 48 weeks
DRUGRibavirin in Arm 1
Arm 1,2,3 Ribavirin in a dose of 13 mg/kg/day orally for 48 weeks
Sponsors
MinaPharm Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
1. The subject signs and dates a written informed consent form (ICF) prior to any study-related activities, including discontinuation of any prohibited medications. 2. 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: 1. 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 2. Childbearing potential, has a negative serum pregnancy test at screening. 3. The subject is between the ages of 20 and 50, inclusive at the time of the screening visit. 4. 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. 5. The subject is or has been diagnosed with Hepatitis C genotype 4. 6. Subjects are treatment Naive 7. Male or female subjects with BMI ≤ 35 . 8. Compensated liver disease with all the following minimum hematological and biochemical criteria: 1. Hemoglobin \> 12 g/dl for males, \>11 g/dl for females. 2. White blood cell count (WBC) \> 3,000 /mm3 - Absolute Neutrophilic count (ANC above 1000) 3. Platelets \> 80,000/mm3 4. Prothrombin time less than 4 seconds above the upper limit of normal (ULN). 5. Serum albumin \> 3.5mg/dl 6. Normal Bilirubin level (except for Gilbert's syndrome where indirect Bilirubin should be \< 3mg/dl) 7. Histological diagnosis of chronic hepatitis with Fibroscan( fibrosis assessment). 8. Normal fasting blood glucose level or within 20% of ULN for non-diabetic patients. If there is a history of diabetes, hemoglobin A1C \<8.5% (as evidence of good glucose control in recent months). 9. Serum Creatinine within normal limits. 10. Thyroid Stimulating Hormone (TSH) within normal limits of testing lab. Patients requiring medications to maintain TSH are eligible if they have fulfilled all other inclusion and
Exclusion criteria
. 11. 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: 1. Alpha Fetoprotein obtained within 3 months of entry. 2. Abdominal Ultrasound within 3 months of entry that is negative for evidence of hepatocellular carcinoma. 3. If Alpha Fetoprotein is above 100 units CT scan of the abdomen that is negative for evidence of hepatocellular carcinoma is required. 12. Patients must be serum hepatitis B surface antigen (HBsAg) negative. 13. Negative Antinuclear Antibodies (ANA) or titer of \< 1:160 14. Serum positive for anti-HCV antibodies and HCV-RNA. 15. Abdominal Ultrasound obtained within one year prior to entry in the study 16. Electrocardiogram for men aged \> 40 years. 17. Normal urine analysis. 18. Normal fundus exam. 19. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Early virological response | 3 months after start of treatment | Early Virological Response (EVR) achieved by undetected Hepatitis C Virus (HCV) RNA after 12 weeks ( 3 months after start of treatment) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sustained Virological Response ( SVR ) | 3 months after end of treatmet ( Week 60) | Sustained Virological Response ( SVR ) achieved by undetected HCV RNA after 1 year and 12 weeks (3 months after end of treatment) . |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety outcome | During the period of study medications taking (up to 48 weeks) | Any adverse event will be found during the period of study medications taking will be recorded . |
Countries
Egypt
Outcome results
None listed