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

September 26, 2008 updated by: Romark Laboratories L.C.

Study of a 4-Week Lead-In With Nitazoxanide Followed By 36 Weeks of Nitazoxanide Plus Peginterferon Alfa-2a in the Treatment of Chronic Hepatitis C

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Tanta, Egypt
        • Digestive Disease Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Drug: 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.
Other Names:
  • Alinia
Biological: 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.
Other Names:
  • PEGASYS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sustained virologic response
Time Frame: 24 weeks after the end of treatment
24 weeks after the end of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
End of treatment virologic response
Time Frame: At the end of treatment
At the end of treatment
Early virologic response
Time Frame: After 12 weeks of combination therapy
After 12 weeks of combination therapy
Rapid virologic response
Time Frame: After 4 weeks of combination therapy
After 4 weeks of combination therapy
ALT normalization
Time Frame: 24 weeks after the end of treatment
24 weeks after the end of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Romark Laboratories L.C.

Investigators

  • Principal Investigator: Asem Elfert, MD, Tanta University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Primary Completion (ACTUAL)

September 1, 2008

Study Completion (ACTUAL)

September 1, 2008

Study Registration Dates

First Submitted

September 26, 2008

First Submitted That Met QC Criteria

September 26, 2008

First Posted (ESTIMATE)

October 1, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

October 1, 2008

Last Update Submitted That Met QC Criteria

September 26, 2008

Last Verified

September 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RM01-3037

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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