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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nitazoxanide-Peginterferon | Experimental | 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. |
|
| Nitazoxanide-Peginterferon-Ribavirin | Experimental | 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. |
|
| Peginterferon-Ribavirin | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nitazoxanide | Drug | One oral nitazoxanide 500 mg tablet with food twice daily for 48 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sustained virologic response | 24 weeks after the end of treatment |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Tropical Medicine & Infectious Diseases, Alexandria University | Alexandria | Egypt | ||||
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| Peginterferon alfa-2a | Biological | Weekly injections of 180µg peginterferon alfa-2a for 36 weeks. |
|
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| Peginterferon alfa-2a | Biological | Weekly injections of 180 µg peginterferon alfa-2a for 48 weeks. |
|
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| Ribavirin | Drug | Oral ribavirin 1000 mg (body weight <75 kg) or 1200 mg (body weight ≥75 kg) daily in two divided doses for 36 weeks. |
|
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| Ribavirin | Drug | Oral ribavirin 1000 mg (body weight <75 kg) or 1200 mg (body weight ≥75 kg) daily in two divided doses for 48 weeks. |
|
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| After 4 weeks of combination therapy |
| ALT normalization | 24 weeks after the end of treatment |
| Department of Tropical Medicine & Infectious Diseases, Tanta University School of Medicine |
| Tanta |
| Egypt |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C041747 | nitazoxanide |
| C100416 | peginterferon alfa-2a |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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