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.
Romark Laboratories L.C.
- Drug: Nitazoxanide
- Drug: Placebo
- Biological: Peginterferon alfa-2a
- Drug: Ribavirin
- 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).
- 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
- Serious or severe bacterial infection(s).
- Ulcerative or hemorrhagic/ischemic colitis.
- History of severe or uncontrolled psychiatric disease, including severe depression,
history of suicidal ideation, suicidal attempts or psychosis requiring medication
- 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.
- History of hypersensitivity or intolerance to nitazoxanide or any of the excipients
comprising the nitazoxanide tablets, peginterferon alfa-2a injectable solution or
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study