Study of Nitazoxanide Combined With Peginterferon Compared to Peginterferon Monotherapy in the Treatment of Hepatitis C

Phase 2

Completed

• Conditions: Chronic Hepatitis C

• Registration Number: NCT00418054
• Lead Sponsor: Romark Laboratories L.C.

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 pre-treated for 24 weeks with nitazoxanide monotherapy in the treatment of chronic hepatitis C.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12
• Study Completion: 2006-07
• Status Verified: 2007-01
• Study First Submitted: 2007-01-03
• Study First Submitted QC: 2007-01-03
• Last Update Submitted: 2007-01-03
• Study First Posted: 2007-01-04
• Last Update Posted: 2007-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 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 Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Virologic response

Secondary Outcome Measures

Name	Time	Method
2 log drop in serum HCV RNA
Change in ALT

Trial Locations

Locations (2)

Department of Tropical Medicine & Infectious Diseases, Alexandria University; 🇪🇬 Alexandria, Egypt

Department of Tropical Medicine & Infectious Diseases, Tanta University School of Medicine; 🇪🇬 Tanta, Egypt