Study of Nitazoxanide, Peginterferon, and Ribavirin Combination Therapies in the Treatment of Chronic Hepatitis C (STEALTHC-1)

September 23, 2008 updated by: Romark Laboratories L.C.

Randomized Study of Nitazoxanide-Peginterferon, Nitazoxanide-Peginterferon-Ribavirin and Peginterferon-Ribavirin in the Treatment of Chronic Hepatitis C

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

121

Phase

  • Phase 2
  • Phase 3

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
      • Alexandria, Egypt
        • Department of Tropical Medicine & Infectious Diseases, Alexandria University
      • Tanta, Egypt
        • Department of Tropical Medicine & Infectious Diseases, Tanta University School of Medicine

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:

  • 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.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Nitazoxanide
One oral nitazoxanide 500 mg tablet with food twice daily for 48 weeks.
Other Names:
  • Alinia
Biological: Peginterferon alfa-2a
Weekly injections of 180µg peginterferon alfa-2a for 36 weeks.
Other Names:
  • PEGASYS
Biological: Peginterferon alfa-2a
Weekly injections of 180 µg peginterferon alfa-2a for 48 weeks.
Other Names:
  • PEGASYS
Experimental: 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.
Drug: Nitazoxanide
One oral nitazoxanide 500 mg tablet with food twice daily for 48 weeks.
Other Names:
  • Alinia
Biological: Peginterferon alfa-2a
Weekly injections of 180µg peginterferon alfa-2a for 36 weeks.
Other Names:
  • PEGASYS
Biological: Peginterferon alfa-2a
Weekly injections of 180 µg peginterferon alfa-2a for 48 weeks.
Other Names:
  • PEGASYS
Drug: Ribavirin
Oral ribavirin 1000 mg (body weight <75 kg) or 1200 mg (body weight ≥75 kg) daily in two divided doses for 36 weeks.
Other Names:
  • COPEGUS
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.
Other Names:
  • COPEGUS
Active Comparator: 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.
Biological: Peginterferon alfa-2a
Weekly injections of 180µg peginterferon alfa-2a for 36 weeks.
Other Names:
  • PEGASYS
Biological: Peginterferon alfa-2a
Weekly injections of 180 µg peginterferon alfa-2a for 48 weeks.
Other Names:
  • PEGASYS
Drug: Ribavirin
Oral ribavirin 1000 mg (body weight <75 kg) or 1200 mg (body weight ≥75 kg) daily in two divided doses for 36 weeks.
Other Names:
  • COPEGUS
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.
Other Names:
  • COPEGUS

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: Yehia El-Gohary, MD, Department of Tropical Medicine & Infectious Diseases, Alexandria University
  • Principal Investigator: Asem Elfert, MD, Department of Tropical Medicine & Infectious Diseases, 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

June 1, 2006

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

January 10, 2007

First Submitted That Met QC Criteria

January 10, 2007

First Posted (Estimate)

January 12, 2007

Study Record Updates

Last Update Posted (Estimate)

September 25, 2008

Last Update Submitted That Met QC Criteria

September 23, 2008

Last Verified

September 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RM01-3036

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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