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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:
Information provided by:
Romark Laboratories L.C.
ClinicalTrials.gov Identifier:
NCT00418054
First received: January 3, 2007
Last updated: NA
Last verified: January 2007
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00418054     History of Changes
Other Study ID Numbers: RM01-2022
Study First Received: January 3, 2007
Last Updated: January 3, 2007
Health Authority: Egypt: Ministry of Health and Population

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis, Chronic
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Interferon-alpha
Nitazoxanide
Peginterferon alfa-2b
Anti-Infective Agents
Antiparasitic Agents
Antiviral Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014