Study of Nitazoxanide, Peginterferon Alfa-2a and Ribavirin for the Treatment of Hepatitis C

NCT ID: NCT00495391

Last Updated: 2014-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2010-02-28

Brief Summary

The purpose of this study is to determine if nitazoxanide in combination with peginterferon alfa-2a and ribavirin is safe and effective in treating chronic hepatitis C in patients that have previously failed to respond to treatment with peginterferon and ribavirin.

Conditions

Chronic Hepatitis C

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

Oral 500 mg nitazoxanide twice daily for 4 weeks followed by oral 500 mg nitazoxanide twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if \<75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.

Group Type: ACTIVE_COMPARATOR

Nitazoxanide

Intervention Type: DRUG

One oral 500 mg nitazoxanide tablet twice daily for 52 weeks.

Peginterferon alfa-2a

Intervention Type: BIOLOGICAL

Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.

Ribavirin

Intervention Type: DRUG

1000 mg (if \<75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.

2

Oral placebo twice daily for 4 weeks followed by oral placebo twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if \<75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

One oral placebo tablet twice daily for 52 weeks.

Peginterferon alfa-2a

Intervention Type: BIOLOGICAL

Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.

Ribavirin

Intervention Type: DRUG

1000 mg (if \<75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.

Interventions

Nitazoxanide

One oral 500 mg nitazoxanide tablet twice daily for 52 weeks.

Intervention Type: DRUG

Placebo

One oral placebo tablet twice daily for 52 weeks.

Intervention Type: DRUG

Peginterferon alfa-2a

Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.

Intervention Type: BIOLOGICAL

Ribavirin

1000 mg (if \<75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.

Intervention Type: DRUG

Other Intervention Names

Alinia; PEGASYS; COPEGUS

Eligibility Criteria

Inclusion Criteria

• Chronic hepatitis C genotype 1.
• Failed to respond to ≥12 weeks of peginterferon and ribavirin (<2 log10 drop in Hepatitis C Virus Ribonucleic Acid (HCV RNA) at week 12 or detectable Hepatitis C Virus Ribonucleic Acid (HCV RNA) at week 24).

Exclusion Criteria

• Females of child-bearing age who are either pregnant, breast-feeding or not using birth control and are sexually active.
• Males whose female partners are either pregnant or of child-bearing potential or not using birth control and are sexually active.
• Other causes of liver disease including autoimmune hepatitis.
• Transplant recipients receiving immune suppression therapy.
• Screening tests positive for Anti-Hepatitis A Virus Immunoglobulin M Antibody (anti-HAV IgM Ab), Hepatitis B's antigen (HBsAg), Anti-Hepatitis B core antigen Immunoglobulin M Antibody (anti-HBc IgM Ab) or Anti-Human Immunodeficiency Virus Antibody (anti-HIV Ab).
• Decompensated cirrhosis, history of variceal bleeding, ascites, hepatic encephalopathy, Child-Turcotte-Pugh (CTP) score >6 or Model for End-stage Liver Disease (MELD) score >8.
• Alcohol consumption of >40 grams per day or an alcohol use pattern that will interfere with the study.
• Absolute neutrophil count <1500 cells/mm3; platelet count <135,000 cells/mm3; hemoglobin <12 g/dL for women and <13 g/dL for men; or serum creatinine concentration ≥1.5 times Upper Limit of Normal (ULN).
• Hypothyroidism or hyperthyroidism not effectively treated with medication.
• Hemoglobin A1C (HgbA1c) >7.5 or history of diabetes mellitus.
• Body Mass Index (BMI) >28.
• History or other clinical evidence of significant or unstable cardiac disease.
• History or other clinical evidence of chronic pulmonary disease associated with functional impairment.
• Serious or severe bacterial infection(s).
• Ulcerative or hemorrhagic/ischemic colitis.
• Pancreatitis.
• History of severe or uncontrolled psychiatric disease, including severe depression, history of suicidal ideation, suicidal attempts or psychosis requiring medication and/or hospitalization.
• History of uncontrolled severe seizure disorder.
• Requires concomitant theophylline or methadone.
• History of immunologically mediated disease requiring more than intermittent anti-inflammatory medications for management or that requires frequent or prolonged use of corticosteroids.
• History or other evidence of severe retinopathy or clinically relevant ophthalmological disorder due to diabetes mellitus or hypertension.
• Hemoglobinopathies.
• History of hypersensitivity or intolerance to nitazoxanide or any of the excipients comprising the nitazoxanide tablets, peginterferon alfa-2a injectable solution or ribavirin tablets.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Romark Laboratories L.C.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Nelson, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida Hepatology

Stephen Harrison, MD

Role: PRINCIPAL_INVESTIGATOR

Brooke Army Medical Center

Arthur Berman, DO

Role: PRINCIPAL_INVESTIGATOR

Florida Center for Gastroenterology

Ronald Pruitt, MD

Role: PRINCIPAL_INVESTIGATOR

Nashville Medical Research Institute

Ahmed Aijaz, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Ramsey Cheung, MD

Role: PRINCIPAL_INVESTIGATOR

VA Palo Alto Health Care System

Ira Jacobson, MD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Mitchell Shiffman, MD

Role: PRINCIPAL_INVESTIGATOR

McGuire VA Medical Center

Joseph Lim, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University Digestive Diseases

Norman Gitlin, MD

Role: PRINCIPAL_INVESTIGATOR

Atlanta Gastroenterology Associates

Locations

VA Palo Alto Healthcare System

Palo Alto, California, United States

Stanford University School of Medicine

Stanford, California, United States

Yale University Digestive Diseases

New Haven, Connecticut, United States

University of Florida Hepatology

Gainesville, Florida, United States

Florida Center for Gastroenterology

Largo, Florida, United States

Atlanta Gastroenterology Associates

Atlanta, Georgia, United States

Weill Cornell Medical College

New York, New York, United States

Nashville Medical Research Institute

Nashville, Tennessee, United States

Brooke Army Medical Center

Fort Sam Houston, Texas, United States

McGuire VA Medical Center

Richmond, Virginia, United States

Countries

United States

Other Identifiers

RM01-2025

Identifier Type: -

Identifier Source: org_study_id