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

Sponsor

Romark Laboratories L.C. (Industry)

Overall Status

Completed

CT.gov ID

NCT00418054

Collaborator

(none)

Enrollment

Locations

Duration (Months)

Patients Per Site

2.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Hepatitis C	Drug: Nitazoxanide plus peginterferon alfa-2b Drug: Peginterferon alfa-2b	Phase 2

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

Phase II, Multi-Center, Randomized, Double-Blind Study of Nitazoxanide Tablets Combined With Peginterferon Compared to Peginterferon Monotherapy in the Treatment of Chronic Hepatitis C

Study Start Date :

Dec 1, 2005

Study Completion Date :

Jul 1, 2006

Outcome Measures

Primary Outcome Measures

Virologic response []

Secondary Outcome Measures

2 log drop in serum HCV RNA []
Change in ALT []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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

Sponsors and Collaborators

Romark Laboratories L.C.

Investigators

Principal Investigator: Yehia El-Gohary, MD, Department of Tropical Medicine & Infectious Diseases, Alexandria University
Principal Investigator: Asem Elfert, MD, Department of Tropical Medicine & Infectious Diseases, Tanta University School of Medicine