Status:
COMPLETED
Study of Nitazoxanide Combined With Peginterferon Compared to Peginterferon Monotherapy in the Treatment of 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 evaluate the safety and efficacy of nitazoxanide-peginterferon alfa-2b combination therapy compared to peginterferon monotherapy in patients that are treatment naive or...
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.
- Patients that have not previously received peginterferon.
Exclusion
- Patients unable to take oral medications.
- Use of ribavirin within 30 days prior to enrollment.
- Females who are either pregnant, breast-feeding or not using birth control and are sexually active.
- Any investigational drug therapy within 30 days prior to enrollment other than through Romark study number RM01-3027.
- Patients with other causes of liver disease.
- Transplant recipients receiving immune suppression therapy.
- Patient co-infected with human immunodeficiency virus, hepatitis A virus, hepatitis B virus, or hepatitis D virus based on enzyme immunoassay.
- Patients with decompensated cirrhosis, thrombocytopenia (platelet count \<80,000), neutropenia, history of variceal bleeding, ascites, hepatic encephalopathy or CTP scores \>6.
- Patients with history of alcoholism (unless abstinent for 2 years) or with an alcohol consumption of \>20 grams per day.
- Patients who are clinically unstable.
- 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 or peginterferon alfa-2b solution for injection.
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
End Date :
July 1 2006
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00418054
Start Date
December 1 2005
End Date
July 1 2006
Last Update
January 4 2007
Active Locations (2)
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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