4-Week Lead-In With Nitazoxanide Followed by 36 Weeks Nitazoxanide and Peginterferon Alfa-2a in Chronic Hepatitis C

Romark Laboratories

Status and phase: Completed; Phase 2

Conditions: Chronic Hepatitis C

Treatments: Drug: Nitazoxanide; Biological: Peginterferon alfa-2a

Study type: Interventional

Funder types: Industry

Identifiers

NCT00763568

RM01-3037

Details and patient eligibility

About

The purpose of this study is to determine if taking nitazoxanide alone for 4 weeks followed by 36 weeks of nitazoxanide plus peginterferon is superior to peginterferon plus ribavirin (standard of care) for 48 weeks.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chronic hepatitis C

Exclusion criteria

• Previously failed to respond to at least 12 weeks of peginterferon plus ribavirin combination therapy.
• Unable to take oral medication.
• Females who are either pregnant, breast-feeding or not using birth control.
• Males whose female partners are pregnant or plan to become pregnant.
• Other causes of liver disease (for example, autoimmune hepatitis, decompensated liver disease).
• Patients with HIV, HAV, HBV or HDV.
• Patients with a history of alcoholism or with an alcohol consumption of more than 40 grams per day.
• Patients with hemoglobinopathies (for example, thalassemia major, sickle-cell anemia).
• History of hypersensitivity or intolerance to nitazoxanide or peginterferon.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Nitazoxanide

Experimental group

Description:

One nitazoxanide 500 mg tablet orally twice a day for 4 weeks followed by one nitazoxanide 500 mg tablet orally twice a day plus weekly injections of 180µg peginterferon alfa-2a for 36 weeks.

Treatment:

Biological: Peginterferon alfa-2a

Drug: Nitazoxanide