Study of the Impact of Nitazoxanide on Chronic Hepatitis Patients
Hepatitis C
About this trial
This is an interventional treatment trial for Hepatitis C focused on measuring chronic hepatitis C, genotype 4, treatment naive patients, Egypt
Eligibility Criteria
Inclusion Criteria:
- Age > 18 and <60.
- Liver biopsy showing chronic hepatitis with significant fibrosis using Ishak scoring system.
- Compensated liver disease; serum bilirubin < 1.5 mg/dl, INR no more than 1.5, serum albumin > 3.4, platelet count >75,000 mm, and no evidence of hepatic decompensation (hepatic encephalopathy or ascites).
- Acceptable hematological and biochemical indices (hemoglobin 13g/dl for men and 12 g/dl for women; neutrophil count 1500/mm3 or more and serum creatinine <1.5 mg/dl.
- Willing to be treated and to adhere to treatment requirements
Exclusion Criteria:
- Major uncontrolled depressive illness.
- Solid organ transplantation.
- Autoimmune conditions, known to be exacerbated by peginterferon and ribavirin.
- Untreated thyroid disease.
- Pregnant or unwilling to comply with adequate contraception.
- Severe concurrent medical disease such as severe hypertension, heart failure, significant coronary heart disease, poorly controlled diabetes, chronic obstructive pulmonary disease.
- Known hypersensitivity to drugs used to treat HCV.
Sites / Locations
- National Liver Institute
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Experimental
placebo
Nitazoxanide
• Group A: comprises 100 chronic hepatitis patients who will receive placebo twice daily orally with food for an average of 12 weeks followed by the standard of care treatment, peginterferon Alfa 2a once weekly and weight-based ribavirin 1000 or 1200 mg/day (based on body weight < 75 kg or ≥ 75 kg, respectively) in divided doses plus placebo twice daily for 48 weeks. All patients in this group will have an HCV RNA within 3 months before initiation of therapy, in addition to ALT levels, CBC and other routine liver function tests.
• Group B: comprises 100 CHC patients who will receive oral Nitazoxanide 500 mg twice daily with food for an average of 12 weeks as a part of monotherapy lead-in phase followed by triple therapy, nitazoxanide 500 mg twice daily plus peginterferon alfa-2a (once weekly), and weight-based ribavirin (1000-1200 mg daily) for 48 weeks. All patients in this group will have an HCV RNA within 3 months before initiation of therapy, in addition to ALT levels, CBC and other routine liver function tests.