Back to resultsStudy of Nitazoxanide in the Treatment of Chronic Hepatitis C
Primary Purpose
Chronic Hepatitis C
Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Nitazoxanide
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Hepatitis C focused on measuring Chronic Hepatitis C
Eligibility 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.
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.
Sites / Locations
- Department of Tropical Medicine & Infectious Diseases, Alexandria University
- Cairo Liver & GIT Center
- Department of Tropical Medicine & Infectious Diseases, Tanta University School of Medicine
Outcomes
Primary Outcome Measures
Virologic response
Secondary Outcome Measures
Sustained virologic response
Quantitative serum HCV RNA
Changes in ALT
Full Information
NCT ID
NCT00418639
First Posted
January 3, 2007
Last Updated
January 3, 2007
Sponsor
Romark Laboratories L.C.
1. Study Identification
Unique Protocol Identification Number
NCT00418639
Brief Title
Study of Nitazoxanide in the Treatment of Chronic Hepatitis C
Official Title
Randomized, Double-Blind, Placebo-Controlled Study of Nitazoxanide in the Treatment of Chronic Hepatitis C
Study Type
Interventional
2. Study Status
Record Verification Date
January 2007
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Romark Laboratories L.C.
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C
Keywords
Chronic Hepatitis C
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
50 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Nitazoxanide
Primary Outcome Measure Information:
Title
Virologic response
Secondary Outcome Measure Information:
Title
Sustained virologic response
Title
Quantitative serum HCV RNA
Title
Changes in ALT
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samir M Kabil, MD
Organizational Affiliation
Cairo Liver & GIT Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yehia El-Gohary, MD
Organizational Affiliation
Department of Tropical Medicine & Infectious Diseases, Alexandria University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Asem Elfert, MD
Organizational Affiliation
Department of Tropical Medicine & Infectious Diseases, Tanta University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Tropical Medicine & Infectious Diseases, Alexandria University
City
Alexandria
Country
Egypt
Facility Name
Cairo Liver & GIT Center
City
Cairo
Country
Egypt
Facility Name
Department of Tropical Medicine & Infectious Diseases, Tanta University School of Medicine
City
Tanta
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Study of Nitazoxanide in the Treatment of Chronic Hepatitis C
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