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

Chronic Hepatitis C Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00418054
• Other study ID #: RM01-2022
• Status: Completed
• Phase: Phase 2
• First received: January 3, 2007
• Last updated: January 3, 2007
• Start date: December 2005
• Est. completion date: July 2006

Study information

• Verified date: January 2007
• Source: Romark Laboratories L.C.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Health and Population
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Nitazoxanide plus peginterferon alfa-2b

• Peginterferon alfa-2b

Locations

Country	Name	City	State
Egypt	Department of Tropical Medicine & Infectious Diseases, Alexandria University	Alexandria
Egypt	Department of Tropical Medicine & Infectious Diseases, Tanta University School of Medicine	Tanta

Sponsors (1)

Lead Sponsor	Collaborator
Romark Laboratories L.C.

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Virologic response
Secondary	2 log drop in serum HCV RNA
Secondary	Change in ALT