Study of Nitazoxanide, Peginterferon, and Ribavirin Combination Therapies in the Treatment of Chronic Hepatitis C

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and efficacy of nitazoxanide-peginterferon and nitazoxanide-peginterferon-ribavirin combination regimens compared to the standard of care (peginterferon-ribavirin) in treating chronic hepatitis C genotype 4. The study will also evaluate the effect of the studied treatment regimens on end of treatment virologic response, ALT normalization and safety parameters.

Official Title
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Randomized Study of Nitazoxanide-Peginterferon, Nitazoxanide-Peginterferon-Ribavirin and Peginterferon-Ribavirin 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
* Biological: Peginterferon alfa-2a
* Drug: Ribavirin
* Drug: Ribavirin


Participation Criteria
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Eligibility Criteria
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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. Exclusion Criteria: Patients who have previously failed to respond to ≥12 weeks of peginterferon-ribavirin combination therapy. Females who are either pregnant, breast-feeding or not using birth control and are sexually active. Males whose female partners are pregnant. Patients with other causes of liver disease (i.e., autoimmune hepatitis, decompensated liver disease). Patients co-infected with hepatitis A virus, hepatitis B virus or hepatitis D virus. Patients with a history of alcoholism or with an alcohol consumption of >40 grams per day. Patients with hemoglobinopathies (i.e., thalassemia major, sickle-cell anemia). 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, peginterferon alfa-2a injectionable solution or ribavirin tablets.

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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nitazoxanide-Peginterferon<br>One oral nitazoxanide 500 mg tablet with food twice daily for 12 weeks followed by 36 weeks of one oral nitazoxanide 500 mg tablet plus weekly injections of 180 µg peginterferon alfa-2a. | Drug: Nitazoxanide<br>* One oral nitazoxanide 500 mg tablet with food twice daily for 48 weeks.<br>* Other names: Alinia;Biological: Peginterferon alfa-2a<br>* Weekly injections of 180µg peginterferon alfa-2a for 36 weeks.<br>* Other names: PEGASYS;|
| Experimental: Nitazoxanide-Peginterferon-Ribavirin<br>One oral nitazoxanide 500 mg tablet with food twice daily for 12 weeks followed by 36 weeks of one oral nitazoxanide 500 mg tablet plus weekly injections of 180 µg peginterferon alfa-2a plus oral ribavirin 1000 mg (body weight <75 kg) or 1200 mg (body weight ≥75 kg) daily in two divided doses. | Drug: Nitazoxanide<br>* One oral nitazoxanide 500 mg tablet with food twice daily for 48 weeks.<br>* Other names: Alinia;Biological: Peginterferon alfa-2a<br>* Weekly injections of 180µg peginterferon alfa-2a for 36 weeks.<br>* Other names: PEGASYS;Drug: Ribavirin<br>* Oral ribavirin 1000 mg (body weight <75 kg) or 1200 mg (body weight ≥75 kg) daily in two divided doses for 36 weeks.<br>* Other names: COPEGUS;|
| Active Comparator: Peginterferon-Ribavirin<br>Weekly injections of 180 µg peginterferon alfa-2a plus oral ribavirin 1000 mg (body weight <75 kg) or 1200 mg (body weight ≥75 kg) daily in two divided doses for 48 weeks. | Biological: Peginterferon alfa-2a<br>* Weekly injections of 180 µg peginterferon alfa-2a for 48 weeks.<br>* Other names: PEGASYS;Drug: Ribavirin<br>* Oral ribavirin 1000 mg (body weight <75 kg) or 1200 mg (body weight ≥75 kg) daily in two divided doses for 48 weeks.<br>* Other names: COPEGUS;|

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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Hepatitis C