Chronic Hepatitis C
Conditions
Brief summary
The purpose of this study is to evaluate the safety and efficacy of nitazoxanide-peginterferon alfa-2b combination therapy compared to peginterferon monotherapy in patients that are treatment naive or pre-treated for 24 weeks with nitazoxanide monotherapy in the treatment of chronic hepatitis C.
Interventions
DRUGNitazoxanide plus peginterferon alfa-2b
DRUGPeginterferon alfa-2b
Sponsors
Romark Laboratories L.C.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
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. * Patients that have not previously received peginterferon.
Exclusion criteria
* Patients unable to take oral medications. * Use of ribavirin within 30 days prior to enrollment. * Females who are either pregnant, breast-feeding or not using birth control and are sexually active. * Any investigational drug therapy within 30 days prior to enrollment other than through Romark study number RM01-3027. * Patients with other causes of liver disease. * Transplant recipients receiving immune suppression therapy. * Patient co-infected with human immunodeficiency virus, hepatitis A virus, hepatitis B virus, or hepatitis D virus based on enzyme immunoassay. * Patients with decompensated cirrhosis, thrombocytopenia (platelet count \<80,000), neutropenia, history of variceal bleeding, ascites, hepatic encephalopathy or CTP scores \>6. * Patients with history of alcoholism (unless abstinent for 2 years) or with an alcohol consumption of \>20 grams per day. * Patients who are clinically unstable. * 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 or peginterferon alfa-2b solution for injection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Virologic response | — |
Secondary
| Measure | Time frame |
|---|---|
| 2 log drop in serum HCV RNA | — |
| Change in ALT | — |
Countries
Egypt
Outcome results
None listed