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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00418054
First Posted: January 4, 2007
Last Update Posted: January 4, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Romark Laboratories L.C.
  Purpose
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
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
  Eligibility

Information from the National Library of Medicine

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

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00418054


Locations
Egypt
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.
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
  More Information

ClinicalTrials.gov Identifier: NCT00418054     History of Changes
Other Study ID Numbers: RM01-2022
First Submitted: January 3, 2007
First Posted: January 4, 2007
Last Update Posted: January 4, 2007
Last Verified: January 2007

Additional relevant MeSH terms:
Hepatitis
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
Interferon-alpha
Nitazoxanide
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Antiparasitic Agents


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