Official Title: “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 Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: September 2008

Intervention(s) in this Clinical Trial

• Drug: Nitazoxanide
  • One oral nitazoxanide 500 mg tablet with food twice daily for 48 weeks.
• Biological: Peginterferon alfa-2a
  • Weekly injections of 180µg peginterferon alfa-2a for 36 weeks.
• Biological: Peginterferon alfa-2a
  • Weekly injections of 180 µg peginterferon alfa-2a for 48 weeks.
• 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.
• 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.

Arms, Groups and Cohorts in this Clinical Trial

• 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.
• 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.
• 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.

Primary Measures

• Sustained virologic response
  • Time Frame: 24 weeks after the end of treatment
    Safety Issue?: No

Secondary Measures

• End of treatment virologic response
  • Time Frame: At the end of treatment
    Safety Issue?: No
• Early virologic response
  • Time Frame: After 12 weeks of combination therapy
    Safety Issue?: No
• Rapid virologic response
  • Time Frame: After 4 weeks of combination therapy
    Safety Issue?: No
• ALT normalization
  • Time Frame: 24 weeks after the end of treatment
    Safety Issue?: 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:

• 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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Romark Laboratories L.C.

Overall Clinical Trial Officials and Contacts

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

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00421434

Study ID Number: RM01-3036

ClinicalTrials.gov Identifier: NCT00421434

Health Authority: Egypt: Ministry of Health and Population