4-Week Lead-In With Nitazoxanide Followed by 36 Weeks Nitazoxanide and Peginterferon Alfa-2a in Chronic Hepatitis C

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Chronic Hepatitis C

Intervention / Treatment
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* Drug: Nitazoxanide
* Biological: Peginterferon alfa-2a


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nitazoxanide<br>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. | Drug: Nitazoxanide<br>* 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.<br>* Other names: Alinia;Biological: Peginterferon alfa-2a<br>* 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.<br>* Other names: PEGASYS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained virologic response |  | 24 weeks after the end of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| End of treatment virologic response |  | At the end of treatment | 
| Early virologic response |  | After 12 weeks of combination therapy | 
| Rapid virologic response |  | After 4 weeks of combination therapy | 
| ALT normalization |  | 24 weeks after the end of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic hepatitis C, Viral hepatitis