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

Romark Laboratories L.C.40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Hepatitis C

Interventions

NitazoxanideDRUG

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.

Peginterferon alfa-2aBIOLOGICAL

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Digestive Disease Center

Tanta, Egypt

Outcomes

Primary Outcomes

Sustained virologic response

Time frame: 24 weeks after the end of treatment

Secondary Outcomes

End of treatment virologic response

Time frame: At the end of treatment

Early virologic response

Time frame: After 12 weeks of combination therapy

Rapid virologic response

Time frame: After 4 weeks of combination therapy

ALT normalization

Time frame: 24 weeks after the end of treatment

Data from ClinicalTrials.gov

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