Chronic Hepatitis C
Conditions
Keywords
Hepatitis 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.
Interventions
DRUGNitazoxanide
One oral nitazoxanide 500 mg tablet with food twice daily for 48 weeks.
BIOLOGICALPeginterferon alfa-2a
Weekly injections of 180µg peginterferon alfa-2a for 36 weeks.
DRUGRibavirin
Oral ribavirin 1000 mg (body weight \<75 kg) or 1200 mg (body weight ≥75 kg) daily in two divided doses for 36 weeks.
Sponsors
Romark Laboratories L.C.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sustained virologic response | 24 weeks after the end of treatment |
Secondary
| Measure | 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 |
Countries
Egypt
Outcome results
None listed