Ramsey Cheung
Study of Nitazoxanide, Peginterferon Alfa-2a and Ribavirin for the Treatment of Hepatitis C
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305 VA Palo Alto Health Care System 3801 Miranda Avenue Palo Alto, CA 94304Brief
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.
Recruiting Status:
No longer recruitingStanford Recruiting Status:
No longer recruitingCondition(s):
Intervention(s):
- Drug: nitazoxanide
Phase:
Phase 2Eligibility
Ages Eligible for Study:
18 years to Any AgeGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
Chronic hepatitis C genotype 1.
Age over or equal to 18
Chronic liver disease consistent with chronic hepatitis C as documented by liver biopsy within 24 months
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).
Key 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 over or equal to 30.
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.
Additional Study Details
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 RibavirinAnticipated start date:
6/5/2007Lead Sponsor:
The Romark Institute for Medical ResearcjCollaborator(s):
- VA Palo Alto Healthcare System
- University of Florida Hepatology, Gainesville
- Florida Center for Gastroenterology
- Nashville Medical Research Institute
- Brooke Army Medical Center
Investigator(s):
- Ramsey Cheung
- Alan K. Cooper
- Ahmad Kamal
- Stevan Alfredo Gonzalez
- Aijaz Ahmed M.D.
Study Type:
InterventionalPurpose:
TreatmentAllocation:
RandomizedMasking:
Double BlindControl:
noneAssignment:
Single GroupEndpoints:
Safety/EfficacyPrimary Outcomes:
- Sustained virologic response (HCV RNA below lower limit of detection) [Time Frame: 24 weeks after end of treatment]
Secondary Outcomes:
- End of treatment response (HCV RNA below lower limit of detection) [Time Frame: At end of treatment]
Total Number to be Enrolled:
60Total Number to be Enrolled at Stanford:
15More Information
Secondary ID(s):
- 98031
- PAIRE
- RM01-2025
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305 VA Palo Alto Health Care System 3801 Miranda Avenue Palo Alto, CA 94304Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
11/5/2008PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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