Status:
COMPLETED
4-Week Lead-In With Nitazoxanide Followed by 36 Weeks Nitazoxanide and Peginterferon Alfa-2a in Chronic Hepatitis C
Lead Sponsor:
Romark Laboratories L.C.
Conditions:
Chronic Hepatitis C
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine if taking nitazoxanide alone for 4 weeks followed by 36 weeks of nitazoxanide plus peginterferon is superior to peginterferon plus ribavirin (standard of care...
Eligibility Criteria
Inclusion
- Chronic hepatitis C
Exclusion
- Previously failed to respond to at least 12 weeks of peginterferon plus ribavirin combination therapy.
- Unable to take oral medication.
- Females who are either pregnant, breast-feeding or not using birth control.
- Males whose female partners are pregnant or plan to become pregnant.
- Other causes of liver disease (for example, autoimmune hepatitis, decompensated liver disease).
- Patients with HIV, HAV, HBV or HDV.
- Patients with a history of alcoholism or with an alcohol consumption of more than 40 grams per day.
- Patients with hemoglobinopathies (for example, thalassemia major, sickle-cell anemia).
- History of hypersensitivity or intolerance to nitazoxanide or peginterferon.
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00763568
Start Date
August 1 2006
End Date
September 1 2008
Last Update
October 1 2008
Active Locations (1)
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1
Digestive Disease Center
Tanta, Egypt