Status:
COMPLETED
Study of Nitazoxanide, Peginterferon, and Ribavirin Combination Therapies in the Treatment of Chronic Hepatitis C
Lead Sponsor:
Romark Laboratories L.C.
Conditions:
Chronic Hepatitis C
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of nitazoxanide-peginterferon and nitazoxanide-peginterferon-ribavirin combination regimens compared to the standard of care (peginterf...
Eligibility Criteria
Inclusion
- Age ≥18 years.
- Chronic hepatitis C infection (at least 6 months) evidenced by a positive enzyme immunoassay for anti-HCV-antibodies and a positive quantitative RT-PCR amplification of HCV RNA.
- Chronic inflammation on liver biopsy compatible with a diagnosis of chronic viral hepatitis.
- HCV genotype 4.
Exclusion
- Patients who have previously failed to respond to ≥12 weeks of peginterferon-ribavirin combination therapy.
- Females who are either pregnant, breast-feeding or not using birth control and are sexually active.
- Males whose female partners are pregnant.
- Patients with other causes of liver disease (i.e., autoimmune hepatitis, decompensated liver disease).
- Patients co-infected with hepatitis A virus, hepatitis B virus or hepatitis D virus.
- Patients with a history of alcoholism or with an alcohol consumption of \>40 grams per day.
- Patients with hemoglobinopathies (i.e., thalassemia major, sickle-cell anemia).
- Patients with any concomitant condition that, in the opinion of the investigator, would preclude evaluation of response or make it unlikely that the contemplated course of therapy and follow-up could be completed.
- History of hypersensitivity or intolerance to any of the excipients comprising the nitazoxanide tablets, peginterferon alfa-2a injectionable solution or ribavirin tablets.
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
121 Patients enrolled
Trial Details
Trial ID
NCT00421434
Start Date
June 1 2006
End Date
September 1 2008
Last Update
September 25 2008
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Department of Tropical Medicine & Infectious Diseases, Alexandria University
Alexandria, Egypt
2
Department of Tropical Medicine & Infectious Diseases, Tanta University School of Medicine
Tanta, Egypt