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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Romark Laboratories L.C.
ClinicalTrials.gov Identifier:
NCT00495391
First received: July 2, 2007
Last updated: April 8, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Chronic Hepatitis C
Drug: Nitazoxanide
Drug: Placebo
Biological: Peginterferon alfa-2a
Drug: Ribavirin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Phase II, Randomized, Double-blind, Placebo-controlled Study of Nitazoxanide in Combination With Peginterferon Alfa-2a and Ribavirin in Patients With Hepatitis C Who Have Failed to Respond to a Prior Course of Peginterferon and Ribavirin

Resource links provided by NLM:


Further study details as provided by Romark Laboratories L.C.:

Primary Outcome Measures:
  • Sustained Virologic Response (HCV RNA Below Lower Limit of Detection) [ Time Frame: 24 weeks after end of treatment ] [ Designated as safety issue: No ]
    Hepatitis C Virus Ribonucleic Acid (HCV RNA) below lower limit of detection 24 weeks after the end of treatment. All others were considered non-responders.


Secondary Outcome Measures:
  • End of Treatment Response (HCV RNA Below Lower Limit of Detection) [ Time Frame: At end of treatment ] [ Designated as safety issue: No ]
    Hepatitis C Virus Ribonucleic Acid (HCV RNA) below lower limit of detection at the end of treatment. All others were considered non-responders.

  • Early Virologic Response (HCV RNA Below Lower Limit of Detection) [ Time Frame: After 12 weeks combination treatment ] [ Designated as safety issue: No ]
    Hepatitis C Virus Ribonucleic Acid (HCV RNA) below lower limit of detection after 12 weeks of combination therapy.

  • Rapid Virologic Response (HCV RNA Below Lower Limit of Detection) [ Time Frame: After 4 weeks combination treatment ] [ Designated as safety issue: No ]
    Hepatitis C Virus Ribonucleic Acid (HCV RNA) below lower limit of detection after 4 weeks of combination therapy.

  • Changes in ALT [ Time Frame: From baseline to week 8 ] [ Designated as safety issue: No ]
    This analysis was conducted using a comparison of changes in Alanine aminotransferase (ALT) from baseline through week 8, week 16, end of treatment and end of follow up.

  • Changes in ALT [ Time Frame: From baseline to week 16 ] [ Designated as safety issue: No ]
    This analysis was conducted using a comparison of changes in Alanine aminotransferase (ALT) from baseline through week 8, week 16, end of treatment and end of follow up.

  • Changes in ALT [ Time Frame: From baseline to end of treatment ] [ Designated as safety issue: No ]
    This analysis was conducted using a comparison of changes in Alanine aminotransferase (ALT) from baseline through week 8, week 16, end of treatment and end of follow up.

  • Changes in ALT [ Time Frame: From baseline to end of follow up ] [ Designated as safety issue: No ]
    This analysis was conducted using a comparison of changes in Alanine aminotransferase (ALT) from baseline through week 8, week 16, end of treatment and end of follow up.


Enrollment: 64
Study Start Date: July 2007
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
Drug: Nitazoxanide
One oral 500 mg nitazoxanide tablet twice daily for 52 weeks.
Other Name: Alinia
Biological: Peginterferon alfa-2a
Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.
Other Name: PEGASYS
Drug: Ribavirin
1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.
Other Name: COPEGUS
Placebo Comparator: 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.
Drug: Placebo
One oral placebo tablet twice daily for 52 weeks.
Biological: Peginterferon alfa-2a
Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.
Other Name: PEGASYS
Drug: Ribavirin
1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.
Other Name: COPEGUS

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00495391

Locations
United States, California
VA Palo Alto Healthcare System
Palo Alto, California, United States, 94304
Stanford University School of Medicine
Stanford, California, United States, 94305
United States, Connecticut
Yale University Digestive Diseases
New Haven, Connecticut, United States, 06520
United States, Florida
University of Florida Hepatology
Gainesville, Florida, United States, 32610
Florida Center for Gastroenterology
Largo, Florida, United States, 33777
United States, Georgia
Atlanta Gastroenterology Associates
Atlanta, Georgia, United States, 30308
United States, New York
Weill Cornell Medical College
New York, New York, United States, 10021
United States, Tennessee
Nashville Medical Research Institute
Nashville, Tennessee, United States, 37205
United States, Texas
Brooke Army Medical Center
Fort Sam Houston, Texas, United States, 78234
United States, Virginia
McGuire VA Medical Center
Richmond, Virginia, United States, 23249
Sponsors and Collaborators
Romark Laboratories L.C.
Investigators
Principal Investigator: David Nelson, MD University of Florida Hepatology
Principal Investigator: Stephen Harrison, MD Brooke Army Medical Center
Principal Investigator: Arthur Berman, DO Florida Center for Gastroenterology
Principal Investigator: Ronald Pruitt, MD Nashville Medical Research Institute
Principal Investigator: Ahmed Aijaz, MD Stanford University
Principal Investigator: Ramsey Cheung, MD VA Palo Alto Healthcare System
Principal Investigator: Ira Jacobson, MD Weill Medical College of Cornell University
Principal Investigator: Mitchell Shiffman, MD McGuire VA Medical Center
Principal Investigator: Joseph Lim, MD Yale University Digestive Diseases
Principal Investigator: Norman Gitlin, MD Atlanta Gastroenterology Associates
  More Information

No publications provided

Responsible Party: Romark Laboratories L.C.
ClinicalTrials.gov Identifier: NCT00495391     History of Changes
Other Study ID Numbers: RM01-2025
Study First Received: July 2, 2007
Results First Received: November 18, 2013
Last Updated: April 8, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Romark Laboratories L.C.:
Hepatitis C, Chronic

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Ribavirin
Peginterferon alfa-2a
Interferon-alpha
Nitazoxanide
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Antiparasitic Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 27, 2014