Study of Nitazoxanide Combined With Peginterferon Compared to Peginterferon Monotherapy in the Treatment of Hepatitis C

Romark Laboratories

Status and phase

Completed

Phase 2

Conditions

Chronic Hepatitis C

Treatments

Drug: Nitazoxanide plus peginterferon alfa-2b

Drug: Peginterferon alfa-2b

Study type

Interventional

Funder types

Industry

Identifiers

NCT00418054

RM01-2022

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.