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

This study is ongoing, but not recruiting participants.

Sponsored by: Romark Laboratories L.C.
Information provided by: Romark Laboratories L.C.
ClinicalTrials.gov Identifier: NCT00495391
  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 II

MedlinePlus related topics:   Hepatitis    Hepatitis C   

Drug Information available for:   Ribavirin    Peginterferon Alfa-2a    Nitazoxanide   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

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 ]

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 ]
  • Early virologic response (HCV RNA below lower limit of detection) [ Time Frame: After 12 weeks combination treatment ] [ Designated as safety issue: No ]
  • Rapid virologic response (HCV RNA below lower limit of detection) [ Time Frame: After 4 weeks combination treatment ] [ Designated as safety issue: No ]
  • Changes in ALT [ Time Frame: From baseline to weeks 8, 16, end of treatment and end of follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment:   60
Study Start Date:   July 2007
Estimated Study Completion Date:   December 2009
Estimated Primary Completion Date:   November 2009 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Active Comparator
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.
Biological: Peginterferon alfa-2a
Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.
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.
2: Placebo Comparator
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.
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.

  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 HCV RNA at week 12 or detectable 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-HAV IgM Ab, HBsAg, anti-HBc IgM Ab or anti-HIV Ab.
  • Decompensated cirrhosis, history of variceal bleeding, ascites, hepatic encephalopathy, CTP score >6 or 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 ULN.
  • Hypothyroidism or hyperthyroidism not effectively treated with medication.
  • HgbA1c >7.5 or history of diabetes mellitus.
  • 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

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

Locations
United States, California
Stanford University School of Medicine    
      Stanford, California, United States, 94305
VA Palo Alto Healthcare System    
      Palo Alto, California, United States, 94304
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 Cornell Medical College    
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


Responsible Party:   Romark Laboratories, L.C. ( Anthony Shane Jackson, PharmD; Director, Medical Science )
Study ID Numbers:   RM01-2025
First Received:   July 2, 2007
Last Updated:   September 23, 2008
ClinicalTrials.gov Identifier:   NCT00495391
Health Authority:   United States: Food and Drug Administration

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

Study placed in the following topic categories:
Interferon-alpha
Liver Diseases
Hepatitis, Chronic
Interferons
Ribavirin
Hepatitis, Viral, Human
Hepatitis
Virus Diseases
Digestive System Diseases
Peginterferon alfa-2a
Hepatitis C
Nitazoxanide
Interferon Alfa-2a
Interferon Alfa-2b
Hepatitis C, Chronic

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
RNA Virus Infections
Flaviviridae Infections
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Antiviral Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Antiparasitic Agents
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents

ClinicalTrials.gov processed this record on November 06, 2008




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