Trial Search Results

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

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Romark Laboratories L.C.

Stanford Investigator(s):

Intervention(s):

  • Drug: Nitazoxanide
  • Drug: Placebo
  • Biological: Peginterferon alfa-2a
  • Drug: Ribavirin

Phase:

Phase 2

Eligibility


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.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Shawna Thunen
6507235512
Not Recruiting