Study of Nitazoxanide in the Treatment of Chronic Hepatitis C

NCT00418639 | Completed Phase 2

• 1 other identifier: RM01-3027
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

Brief Summary

This study will evaluate the effect of treatment with 24 weeks nitazoxanide monotherapy on end of treatment virologic response, sustained virologic response, reduction of quantitative serum HCV RNA, changes in ALT and safety parameters.

Conditions

Chronic Hepatitis C

Keywords

Chronic Hepatitis C

Outcome Measures

Primary Outcomes (1)

• Virologic response

Secondary Outcomes (3)

• Sustained virologic response

• Quantitative serum HCV RNA

• Changes in ALT

Interventions

Nitazoxanide DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients unable to take oral medications.
• Use of interferon alpha within 90 days or ribavirin within 30 days prior to enrollment.
• Females of child bearing age who are either pregnant, breast-feeding or not using birth control and are sexually active.
• Any investigational drug therapy within 30 days prior to enrollment.
• Patients with other causes of liver disease.
• Patients co-infected with hepatitis A virus, hepatitis B virus or hepatitis D virus based on enzyme immunoassay.
• Patients with history of alcoholism or with an alcohol consumption of \>40 grams per day.
• Patients who are clinically unstable.
• 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 nitazoxanide or any of the excipients comprising the nitazoxanide tablets.

Sponsors & Collaborators

• Romark Laboratories L.C.: lead

Study Sites (3)

Department of Tropical Medicine & Infectious Diseases, Alexandria University

Alexandria, Egypt

Location

Cairo Liver & GIT Center

Cairo, Egypt

Location

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

Tanta, Egypt

Location

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

nitazoxanide

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Samir M Kabil, MD

  Cairo Liver & GIT Center

  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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 3, 2007
• First Posted: January 5, 2007
• Study Start: February 1, 2005
• Last Updated: January 5, 2007

Record last verified: 2007-01

Locations

EG (3)