Status:
COMPLETED
Study of the Impact of Nitazoxanide on Chronic Hepatitis Patients
Lead Sponsor:
National Liver Institute, Egypt
Conditions:
Hepatitis C
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
PHASE3
Brief Summary
The main objective of antiviral therapy of patients with chronic hepatitis C (CHC) is the sustained elimination of the hepatitis C virus (HCV). The standard of care (SOC) is peginterferon alfa-2a/-2b ...
Detailed Description
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 po...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT01197157
Start Date
September 1 2010
End Date
April 1 2014
Last Update
September 30 2014
Active Locations (1)
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1
National Liver Institute
Shebin El-Kom, Monufia Governorate, Egypt