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

This study has been completed.
Information provided by:
Romark Laboratories L.C. Identifier:
First received: January 3, 2007
Last updated: NA
Last verified: January 2007
History: No changes posted
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 Intervention Phase
Chronic Hepatitis C
Drug: Nitazoxanide plus peginterferon alfa-2b
Drug: Peginterferon alfa-2b
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:

Further study details as provided by Romark Laboratories L.C.:

Primary Outcome Measures:
  • Virologic response

Secondary Outcome Measures:
  • 2 log drop in serum HCV RNA
  • Change in ALT

Estimated Enrollment: 40
Study Start Date: December 2005
Estimated Study Completion Date: July 2006

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT00418054

Department of Tropical Medicine & Infectious Diseases, Alexandria University
Alexandria, Egypt
Department of Tropical Medicine & Infectious Diseases, Tanta University School of Medicine
Tanta, Egypt
Sponsors and Collaborators
Romark Laboratories L.C.
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
  More Information Identifier: NCT00418054     History of Changes
Other Study ID Numbers: RM01-2022
Study First Received: January 3, 2007
Last Updated: January 3, 2007

Additional relevant MeSH terms:
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Peginterferon alfa-2b
Antiparasitic Agents
Anti-Infective Agents
Antiviral Agents
Immunologic Factors
Physiological Effects of Drugs processed this record on May 23, 2017