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

Primary Purpose

Chronic Hepatitis C

Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Nitazoxanide
Peginterferon alfa-2a
Peginterferon alfa-2a
Ribavirin
Ribavirin
Sponsored by
Romark Laboratories L.C.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis C focused on measuring Hepatitis C

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Nitazoxanide-Peginterferon

Nitazoxanide-Peginterferon-Ribavirin

Peginterferon-Ribavirin

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Sustained virologic response

Secondary Outcome Measures

End of treatment virologic response
Early virologic response
Rapid virologic response
ALT normalization

Full Information

First Posted
January 10, 2007
Last Updated
September 23, 2008
Sponsor
Romark Laboratories L.C.
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1. Study Identification

Unique Protocol Identification Number
NCT00421434
Brief Title
Study of Nitazoxanide, Peginterferon, and Ribavirin Combination Therapies in the Treatment of Chronic Hepatitis C
Acronym
STEALTHC-1
Official Title
Randomized Study of Nitazoxanide-Peginterferon, Nitazoxanide-Peginterferon-Ribavirin and Peginterferon-Ribavirin in the Treatment of Chronic Hepatitis C
Study Type
Interventional

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Romark Laboratories L.C.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C
Keywords
Hepatitis C

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
121 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nitazoxanide-Peginterferon
Arm Type
Experimental
Arm Description
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.
Arm Title
Nitazoxanide-Peginterferon-Ribavirin
Arm Type
Experimental
Arm Description
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.
Arm Title
Peginterferon-Ribavirin
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Nitazoxanide
Other Intervention Name(s)
Alinia
Intervention Description
One oral nitazoxanide 500 mg tablet with food twice daily for 48 weeks.
Intervention Type
Biological
Intervention Name(s)
Peginterferon alfa-2a
Other Intervention Name(s)
PEGASYS
Intervention Description
Weekly injections of 180µg peginterferon alfa-2a for 36 weeks.
Intervention Type
Biological
Intervention Name(s)
Peginterferon alfa-2a
Other Intervention Name(s)
PEGASYS
Intervention Description
Weekly injections of 180 µg peginterferon alfa-2a for 48 weeks.
Intervention Type
Drug
Intervention Name(s)
Ribavirin
Other Intervention Name(s)
COPEGUS
Intervention Description
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
Intervention Name(s)
Ribavirin
Other Intervention Name(s)
COPEGUS
Intervention Description
Oral ribavirin 1000 mg (body weight <75 kg) or 1200 mg (body weight ≥75 kg) daily in two divided doses for 48 weeks.
Primary Outcome Measure Information:
Title
Sustained virologic response
Time Frame
24 weeks after the end of treatment
Secondary Outcome Measure Information:
Title
End of treatment virologic response
Time Frame
At the end of treatment
Title
Early virologic response
Time Frame
After 12 weeks of combination therapy
Title
Rapid virologic response
Time Frame
After 4 weeks of combination therapy
Title
ALT normalization
Time Frame
24 weeks after the end of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yehia El-Gohary, MD
Organizational Affiliation
Department of Tropical Medicine & Infectious Diseases, Alexandria University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Asem Elfert, MD
Organizational Affiliation
Department of Tropical Medicine & Infectious Diseases, Tanta University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Tropical Medicine & Infectious Diseases, Alexandria University
City
Alexandria
Country
Egypt
Facility Name
Department of Tropical Medicine & Infectious Diseases, Tanta University School of Medicine
City
Tanta
Country
Egypt

12. IPD Sharing Statement

Learn more about this trial

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

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