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

NCT ID: NCT00763568

Last Updated: 2008-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2008-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Hepatitis C

Keywords

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Chronic hepatitis C Viral hepatitis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nitazoxanide

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.

Group Type EXPERIMENTAL

Nitazoxanide

Intervention Type DRUG

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-2a

Intervention Type BIOLOGICAL

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.

Interventions

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Nitazoxanide

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.

Intervention Type DRUG

Peginterferon alfa-2a

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.

Intervention Type BIOLOGICAL

Other Intervention Names

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Alinia PEGASYS

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Romark Laboratories L.C.

INDUSTRY

Sponsor Role lead

Responsible Party

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Romark Laboratories, L.C.

Principal Investigators

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Asem Elfert, MD

Role: PRINCIPAL_INVESTIGATOR

Tanta University School of Medicine

Locations

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Digestive Disease Center

Tanta, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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RM01-3037

Identifier Type: -

Identifier Source: org_study_id