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Study of Nitazoxanide, Peginterferon, and Ribavirin Combination Therapies in the Treatment of Chronic Hepatitis C

NCT ID: NCT00421434

Last Updated: 2008-09-25

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/PHASE3

Total Enrollment

121 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2008-09-30

Brief Summary

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The purpose of this study is to evaluate the safety and efficacy of nitazoxanide-peginterferon and nitazoxanide-peginterferon-ribavirin combination regimens compared to the standard of care (peginterferon-ribavirin) in treating chronic hepatitis C genotype 4. The study will also evaluate the effect of the studied treatment regimens on end of treatment virologic response, ALT normalization and safety parameters.

Detailed Description

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Conditions

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Chronic Hepatitis C

Keywords

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Hepatitis C

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nitazoxanide-Peginterferon

One oral nitazoxanide 500 mg tablet with food twice daily for 12 weeks followed by 36 weeks of one oral nitazoxanide 500 mg tablet plus weekly injections of 180 µg peginterferon alfa-2a.

Group Type EXPERIMENTAL

Nitazoxanide

Intervention Type DRUG

One oral nitazoxanide 500 mg tablet with food twice daily for 48 weeks.

Peginterferon alfa-2a

Intervention Type BIOLOGICAL

Weekly injections of 180µg peginterferon alfa-2a for 36 weeks.

Nitazoxanide-Peginterferon-Ribavirin

One oral nitazoxanide 500 mg tablet with food twice daily for 12 weeks followed by 36 weeks of one oral nitazoxanide 500 mg tablet plus weekly injections of 180 µg peginterferon alfa-2a plus oral ribavirin 1000 mg (body weight \<75 kg) or 1200 mg (body weight ≥75 kg) daily in two divided doses.

Group Type EXPERIMENTAL

Nitazoxanide

Intervention Type DRUG

One oral nitazoxanide 500 mg tablet with food twice daily for 48 weeks.

Peginterferon alfa-2a

Intervention Type BIOLOGICAL

Weekly injections of 180µg peginterferon alfa-2a for 36 weeks.

Ribavirin

Intervention Type DRUG

Oral ribavirin 1000 mg (body weight \<75 kg) or 1200 mg (body weight ≥75 kg) daily in two divided doses for 36 weeks.

Peginterferon-Ribavirin

Weekly injections of 180 µg peginterferon alfa-2a plus oral ribavirin 1000 mg (body weight \<75 kg) or 1200 mg (body weight ≥75 kg) daily in two divided doses for 48 weeks.

Group Type ACTIVE_COMPARATOR

Peginterferon alfa-2a

Intervention Type BIOLOGICAL

Weekly injections of 180 µg peginterferon alfa-2a for 48 weeks.

Ribavirin

Intervention Type DRUG

Oral ribavirin 1000 mg (body weight \<75 kg) or 1200 mg (body weight ≥75 kg) daily in two divided doses for 48 weeks.

Interventions

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Nitazoxanide

One oral nitazoxanide 500 mg tablet with food twice daily for 48 weeks.

Intervention Type DRUG

Peginterferon alfa-2a

Weekly injections of 180µg peginterferon alfa-2a for 36 weeks.

Intervention Type BIOLOGICAL

Peginterferon alfa-2a

Weekly injections of 180 µg peginterferon alfa-2a for 48 weeks.

Intervention Type BIOLOGICAL

Ribavirin

Oral ribavirin 1000 mg (body weight \<75 kg) or 1200 mg (body weight ≥75 kg) daily in two divided doses for 36 weeks.

Intervention Type DRUG

Ribavirin

Oral ribavirin 1000 mg (body weight \<75 kg) or 1200 mg (body weight ≥75 kg) daily in two divided doses for 48 weeks.

Intervention Type DRUG

Other Intervention Names

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Alinia PEGASYS PEGASYS COPEGUS COPEGUS

Eligibility Criteria

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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.

Exclusion Criteria

* Patients who have previously failed to respond to ≥12 weeks of peginterferon-ribavirin combination therapy.
* Females who are either pregnant, breast-feeding or not using birth control and are sexually active.
* Males whose female partners are pregnant.
* Patients with other causes of liver disease (i.e., autoimmune hepatitis, decompensated liver disease).
* Patients co-infected with hepatitis A virus, hepatitis B virus or hepatitis D virus.
* Patients with a history of alcoholism or with an alcohol consumption of \>40 grams per day.
* Patients with hemoglobinopathies (i.e., thalassemia major, sickle-cell anemia).
* 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, peginterferon alfa-2a injectionable solution or ribavirin tablets.
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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Yehia El-Gohary, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Tropical Medicine & Infectious Diseases, Alexandria University

Asem Elfert, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Tropical Medicine & Infectious Diseases, Tanta University School of Medicine

Locations

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Department of Tropical Medicine & Infectious Diseases, Alexandria University

Alexandria, , Egypt

Site Status

Department of Tropical Medicine & Infectious Diseases, Tanta University School of Medicine

Tanta, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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RM01-3036

Identifier Type: -

Identifier Source: org_study_id