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

Sponsor:	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

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

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis C

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

U.S. FDA Resources

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

No publications provided

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

Keywords provided by Romark Laboratories L.C.:

Hepatitis C, Chronic

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Liver Diseases
Flaviviridae Infections
Hepatitis, Chronic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Ribavirin
Physiological Effects of Drugs
Hepatitis, Viral, Human
Antiparasitic Agents
Therapeutic Uses
Growth Inhibitors
Hepatitis C

Angiogenesis Modulating Agents
RNA Virus Infections
Growth Substances
Antiviral Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Virus Diseases
Hepatitis
Digestive System Diseases
Peginterferon alfa-2a
Nitazoxanide
Interferon Alfa-2a
Hepatitis C, Chronic

ClinicalTrials.gov processed this record on November 30, 2009