Study of Nitazoxanide in the Treatment of Chronic 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
This study will evaluate the effect of treatment with 24 weeks nitazoxanide monotherapy on end of treatment virologic response, sustained virologic response, reduction of quantitative serum HCV RNA, changes in ALT and safety parameters.

Condition Intervention Phase
Chronic Hepatitis C
Drug: Nitazoxanide
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: Randomized, Double-Blind, Placebo-Controlled Study of Nitazoxanide 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:
  • Sustained virologic response
  • Quantitative serum HCV RNA
  • Changes in ALT

Estimated Enrollment: 50
Study Start Date: February 2005

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Exclusion Criteria:

  • Patients unable to take oral medications.
  • Use of interferon alpha within 90 days or ribavirin within 30 days prior to enrollment.
  • Females of child bearing age 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.
  • Patients with other causes of liver disease.
  • Patients co-infected with hepatitis A virus, hepatitis B virus or hepatitis D virus based on enzyme immunoassay.
  • Patients with history of alcoholism or with an alcohol consumption of >40 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 nitazoxanide or any of the excipients comprising the nitazoxanide tablets.
  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 identifier: NCT00418639

Department of Tropical Medicine & Infectious Diseases, Alexandria University
Alexandria, Egypt
Cairo Liver & GIT Center
Cairo, Egypt
Department of Tropical Medicine & Infectious Diseases, Tanta University School of Medicine
Tanta, Egypt
Sponsors and Collaborators
Romark Laboratories L.C.
Principal Investigator: Samir M Kabil, MD Cairo Liver & GIT Center
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: NCT00418639     History of Changes
Other Study ID Numbers: RM01-3027 
Study First Received: January 3, 2007
Last Updated: January 3, 2007
Health Authority: Egypt: Ministry of Health and Population

Keywords provided by Romark Laboratories L.C.:
Chronic Hepatitis C

Additional relevant MeSH terms:
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
Anti-Infective Agents
Antiparasitic Agents processed this record on May 30, 2016