Study of Nitazoxanide, Peginterferon, and Ribavirin Combination Therapies in the Treatment of Chronic Hepatitis C
Phase 2
Completed
- Conditions
- Chronic Hepatitis C
- Interventions
- Registration Number
- NCT00421434
- Lead Sponsor
- Romark Laboratories L.C.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 121
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Nitazoxanide-Peginterferon Peginterferon alfa-2a 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 Peginterferon alfa-2a 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 Peginterferon alfa-2a 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. Peginterferon-Ribavirin Ribavirin 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. Nitazoxanide-Peginterferon-Ribavirin Nitazoxanide 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. Nitazoxanide-Peginterferon Nitazoxanide 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 Ribavirin 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.
- Primary Outcome Measures
Name Time Method Sustained virologic response 24 weeks after the end of treatment
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (2)
Department of Tropical Medicine & Infectious Diseases, Alexandria University
🇪🇬Alexandria, Egypt
Department of Tropical Medicine & Infectious Diseases, Tanta University School of Medicine
🇪🇬Tanta, Egypt