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Search / Trial NCT01197157

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

Chronic Hepatitis C Genotype 4 Treatment Naive Patients Egypt

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.

Locations

Shebin El Kom, Menoufiya, Egypt

Patients applied

0 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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