CompletedNCT00421434STEALTHC-1Updated Sep 25, 2008

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

A Phase 2/3 interventional study of Nitazoxanide and Peginterferon alfa-2a in Chronic Hepatitis C, sponsored by Romark Laboratories L.C.. Completed at 2 sites in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-09-25.

Sponsored by Romark Laboratories L.C. · Phase 2/3, Interventional, and Treatment

Phase: Phase 2/3
Study type: Interventional
Enrollment: 121
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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.

Conditions studied

Chronic Hepatitis C

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Keywords

Hepatitis C

In context

Hepatitis A

2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

This study's enrollment of 121 is above the median of 100 across 1,886 interventional studies indexed under Hepatitis A.

Browse Hepatitis A studies →

Lead sponsor

Romark Laboratories L.C. is the lead sponsor of 29 studies on the registry; none are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 7 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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

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 design

Phase: Phase 2 / Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 121 participants (actual)

Study arms

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 · Biological: Peginterferon alfa-2a
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 · Biological: Peginterferon alfa-2a · Drug: Ribavirin
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 · Drug: Ribavirin

Interventions

DrugNitazoxanide
One oral nitazoxanide 500 mg tablet with food twice daily for 48 weeks.
Also known as: Alinia
BiologicalPeginterferon alfa-2a
Weekly injections of 180µg peginterferon alfa-2a for 36 weeks.
Also known as: PEGASYS
BiologicalPeginterferon alfa-2a
Weekly injections of 180 µg peginterferon alfa-2a for 48 weeks.
Also known as: PEGASYS
DrugRibavirin
Oral ribavirin 1000 mg (body weight \<75 kg) or 1200 mg (body weight ≥75 kg) daily in two divided doses for 36 weeks.
Also known as: COPEGUS
DrugRibavirin
Oral ribavirin 1000 mg (body weight \<75 kg) or 1200 mg (body weight ≥75 kg) daily in two divided doses for 48 weeks.
Also known as: COPEGUS

What researchers measure

Primary outcomes

Sustained virologic response
Time frame: 24 weeks after the end of treatment

Secondary outcomes

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

Study locations

2 sites

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

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 25, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00421434
Lead sponsor: Romark Laboratories L.C.
First posted: Jan 12, 2007
Start date: Jun 2006
Primary completion: Sep 2008
Completion: Sep 2008
Last update: Sep 25, 2008

Study contacts

Yehia El-Gohary, MD

principal investigator · Department of Tropical Medicine & Infectious Diseases, Alexandria University

Asem Elfert, MD

principal investigator · Department of Tropical Medicine & Infectious Diseases, Tanta University School of Medicine

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2008. You cannot join it, but the record below documents what was studied.

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