4-Week Lead-In With Nitazoxanide Followed by 36 Weeks Nitazoxanide and Peginterferon Alfa-2a in Chronic Hepatitis C
Information source: Romark Laboratories L.C.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Hepatitis C
Intervention: Nitazoxanide (Drug); Peginterferon alfa-2a (Biological)
Phase: Phase 2
Status: Completed
Sponsored by: Romark Laboratories L.C. Official(s) and/or principal investigator(s): Asem Elfert, MD, Principal Investigator, Affiliation: Tanta University School of Medicine
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) for 48 weeks.
Clinical Details
Official title: Study of a 4-Week Lead-In With Nitazoxanide Followed By 36 Weeks of Nitazoxanide Plus Peginterferon Alfa-2a in the Treatment of Chronic Hepatitis C
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Sustained virologic response
Secondary outcome: End of treatment virologic responseEarly virologic response Rapid virologic response ALT normalization
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Chronic hepatitis C
Exclusion Criteria:
- 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.
Locations and Contacts
Digestive Disease Center, Tanta, Egypt
Additional Information
Starting date: August 2006
Last updated: September 26, 2008
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