Back to results4-Week Lead-In With Nitazoxanide Followed by 36 Weeks Nitazoxanide and Peginterferon Alfa-2a in Chronic Hepatitis C
Primary Purpose
Chronic Hepatitis C
Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Nitazoxanide
Peginterferon alfa-2a
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Hepatitis C focused on measuring Chronic hepatitis C, Viral hepatitis
Eligibility Criteria
Inclusion Criteria:
- Chronic hepatitis C
Exclusion Criteria:
- Previously failed to respond to at least 12 weeks of peginterferon plus ribavirin combination therapy.
- Unable to take oral medication.
- Females who are either pregnant, breast-feeding or not using birth control.
- Males whose female partners are pregnant or plan to become pregnant.
- Other causes of liver disease (for example, autoimmune hepatitis, decompensated liver disease).
- Patients with HIV, HAV, HBV or HDV.
- Patients with a history of alcoholism or with an alcohol consumption of more than 40 grams per day.
- Patients with hemoglobinopathies (for example, thalassemia major, sickle-cell anemia).
- History of hypersensitivity or intolerance to nitazoxanide or peginterferon.
Sites / Locations
- Digestive Disease Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Nitazoxanide
Arm Description
One nitazoxanide 500 mg tablet orally twice a day for 4 weeks followed by one nitazoxanide 500 mg tablet orally twice a day plus weekly injections of 180µg peginterferon alfa-2a for 36 weeks.
Outcomes
Primary Outcome Measures
Sustained virologic response
Secondary Outcome Measures
End of treatment virologic response
Early virologic response
Rapid virologic response
ALT normalization
Full Information
NCT ID
NCT00763568
First Posted
September 26, 2008
Last Updated
September 26, 2008
Sponsor
Romark Laboratories L.C.
1. Study Identification
Unique Protocol Identification Number
NCT00763568
Brief Title
4-Week Lead-In With Nitazoxanide Followed by 36 Weeks Nitazoxanide and Peginterferon Alfa-2a in Chronic Hepatitis C
Official Title
Study of a 4-Week Lead-In With Nitazoxanide Followed By 36 Weeks of Nitazoxanide Plus Peginterferon Alfa-2a in the Treatment of Chronic Hepatitis C
Study Type
Interventional
2. Study Status
Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Romark Laboratories L.C.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine if taking nitazoxanide alone for 4 weeks followed by 36 weeks of nitazoxanide plus peginterferon is superior to peginterferon plus ribavirin (standard of care) for 48 weeks.
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, Viral hepatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nitazoxanide
Arm Type
Experimental
Arm Description
One nitazoxanide 500 mg tablet orally twice a day for 4 weeks followed by one nitazoxanide 500 mg tablet orally twice a day plus weekly injections of 180µg peginterferon alfa-2a for 36 weeks.
Intervention Type
Drug
Intervention Name(s)
Nitazoxanide
Other Intervention Name(s)
Alinia
Intervention Description
One nitazoxanide 500 mg tablet orally twice a day for 4 weeks followed by one nitazoxanide 500 mg tablet orally twice a day plus weekly injections of 180µg peginterferon alfa-2a for 36 weeks.
Intervention Type
Biological
Intervention Name(s)
Peginterferon alfa-2a
Other Intervention Name(s)
PEGASYS
Intervention Description
One nitazoxanide 500 mg tablet orally twice a day for 4 weeks followed by one nitazoxanide 500 mg tablet orally twice a day plus weekly injections of 180µg peginterferon alfa-2a for 36 weeks.
Primary Outcome Measure Information:
Title
Sustained virologic response
Time Frame
24 weeks after the end of treatment
Secondary Outcome Measure Information:
Title
End of treatment virologic response
Time Frame
At the end of treatment
Title
Early virologic response
Time Frame
After 12 weeks of combination therapy
Title
Rapid virologic response
Time Frame
After 4 weeks of combination therapy
Title
ALT normalization
Time Frame
24 weeks after the end of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Chronic hepatitis C
Exclusion Criteria:
Previously failed to respond to at least 12 weeks of peginterferon plus ribavirin combination therapy.
Unable to take oral medication.
Females who are either pregnant, breast-feeding or not using birth control.
Males whose female partners are pregnant or plan to become pregnant.
Other causes of liver disease (for example, autoimmune hepatitis, decompensated liver disease).
Patients with HIV, HAV, HBV or HDV.
Patients with a history of alcoholism or with an alcohol consumption of more than 40 grams per day.
Patients with hemoglobinopathies (for example, thalassemia major, sickle-cell anemia).
History of hypersensitivity or intolerance to nitazoxanide or peginterferon.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Asem Elfert, MD
Organizational Affiliation
Tanta University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Digestive Disease Center
City
Tanta
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
4-Week Lead-In With Nitazoxanide Followed by 36 Weeks Nitazoxanide and Peginterferon Alfa-2a in Chronic Hepatitis C
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