Clinical trial NCT00637923: Study of Nitazoxanide, Peginterferon Alfa-2a and Ribavirin in Treatment-Naive Hepatitis C Patients
Official title: Phase II, Randomized, Double-blind, Placebo-controlled Study of Nitazoxanide in Combination With Peginterferon Alfa-2a and Ribavirin in Treatment-Naive Patients With Hepatitis C
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Hepatitis C
Keywords: Hepatitis C, Chronic
Lead sponsor: Romark Laboratories L.C.
Sponsor class: INDUSTRY
First posted: 2008-03-18
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 treatment-naive patients.


Eligibility criteria: Inclusion Criteria:

* Chronic hepatitis C genotype 1.

Exclusion Criteria:

* Patients that have previously received treatment with any interferon or interferon-based treatment for chronic hepatitis C.
* 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 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) \>34.
* 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.

Primary outcomes:
measure: Sustained Virologic Response (HCV RNA Below Lower Limit of Detection)
timeFrame: 24 weeks after end of treatment
Secondary outcomes:
measure: End of Treatment Response (HCV RNA Below Lower Limit of Detection)
timeFrame: At end of treatment
measure: Early Virologic Response (HCV RNA Below Lower Limit of Detection)
timeFrame: After 12 weeks combination treatment
measure: Rapid Virologic Response (HCV RNA Below Lower Limit of Detection)
timeFrame: After 4 weeks combination treatment
measure: Changes in ALT
timeFrame: From baseline to week 8
measure: Changes in ALT
timeFrame: From baseline to week 16
measure: Changes in ALT
timeFrame: From baseline to end of treatment
measure: Changes in ALT
timeFrame: From baseline to end of follow up
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Palo Alto VA Healthcare System
state: California
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Bay Pines
country: United States
facility: Bay Pines VA Healthcare System
state: Florida
city: Largo
country: United States
facility: Florida Center for Gastroenterology
state: Florida
city: Atlanta
country: United States
facility: Atlanta Gastroenterology Associates
state: Georgia
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: New York
country: United States
facility: New York Presbyterian-Weill Medical College of Cornell University
state: New York
city: Nashville
country: United States
facility: Nashville Medical Research Institute
state: Tennessee
city: Fairfax
country: United States
facility: Metropolitan Research
state: Virginia
Study officials:
affiliation: Romark Laboratories L.C.
name: Emmet B Keeffe, MD, MACP
role: STUDY_DIRECTOR
affiliation: Atlanta Gastroenterology Associates
name: Norman Gitlin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale University
name: Joseph K Lim, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: New York Presbyterial-Weill Medical College of Cornell University
name: Ira Jacobson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: McGuire Veteran's Administration Medical Center
name: Mitchell L Shiffman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nashville Medical Research Institute
name: Ronald E Pruitt, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Florida Center for Gastroenterology
name: Arthur Berman, DO
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Louis University Medical Center
name: Bruce Bacon, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Beth Israel Deaconess Medical Center
name: Nezam Afdhal, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Bay Pines VA Healthcare System
name: David Johnson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachusetts General Hospital
name: Raymond Chung, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Metropolitan Research
name: Vinod Rustgi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Aijaz Ahmed, MD
role: PRINCIPAL_INVESTIGATOR
References: