Study of the Impact of Nitazoxanide on Chronic Hepatitis Patients
Launched by NATIONAL LIVER INSTITUTE, EGYPT · Sep 8, 2010
Trial Information
Current as of June 26, 2025
Completed
Keywords
ClinConnect Summary
Chronic hepatitis C virus (CHC) infects approximately 170 million individuals worldwide. Egypt has the highest hepatitis C virus prevalence in the world (overall prevalence is 12% among the general population, and up to 40% in persons above 40 years of age and is more in rural areas.
Approximately, 90% of hepatitis C patients in Egypt are infected with HCV genotype 4.
The main objective of antiviral therapy of patients with chronic hepatitis C is the sustained elimination of the hepatitis C virus (HCV).
The standard of care for the treatment of chronic hepatitis C is a 24- to 48- week co...
Gender
ALL
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.
About National Liver Institute, Egypt
The National Liver Institute (NLI) in Egypt is a leading research and clinical institution dedicated to advancing the understanding and treatment of liver diseases. Renowned for its commitment to excellence in hepatology, the NLI conducts innovative clinical trials aimed at evaluating new therapies and improving patient outcomes. With a multidisciplinary team of experts, state-of-the-art facilities, and a strong focus on translational research, the institute plays a pivotal role in shaping liver health policies and enhancing clinical practices in the region. By fostering collaboration with international research entities, the National Liver Institute is at the forefront of liver disease research and education in Egypt and beyond.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Shebin El Kom, Menoufiya, Egypt
Patients applied
Trial Officials
Mohamed A Kohla, MD
Principal Investigator
National Liver Institute, Menoufiya University, Egypt
Hossam A Taha, MD
Study Director
National Liver Institute, Menoufiya University, Egypt
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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