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

NCT00418054 | Completed Phase 2

• 1 other identifier: RM01-2022
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Hepatitis C

Outcome Measures

Primary Outcomes (1)

• Virologic response

Secondary Outcomes (2)

• 2 log drop in serum HCV RNA

• Change in ALT

Interventions

Nitazoxanide plus peginterferon alfa-2b DRUG

Peginterferon alfa-2b DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Romark Laboratories L.C.: lead

Study Sites (2)

Department of Tropical Medicine & Infectious Diseases, Alexandria University

Alexandria, Egypt

Location

Department of Tropical Medicine & Infectious Diseases, Tanta University School of Medicine

Tanta, Egypt

Location

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

nitazoxanide; peginterferon alfa-2b

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 3, 2007
• First Posted: January 4, 2007
• Study Start: December 1, 2005
• Study Completion: July 1, 2006
• Last Updated: January 4, 2007

Record last verified: 2007-01

Locations

EG (2)