Ramsey Cheung
Study of Nitazoxanide with Peginteferon and ribivirin in people whith hepatitis c who have never been treated.
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
To evaluate the safety and efficacy of nitazoxanide plus peginterferon a-2a and ribavirin for the treatment of chronic hepatitis C in patients who treatment naive (heve never been treated for hepatitis c.
Recruiting Status:
No longer recruitingStanford Recruiting Status:
No longer recruitingCondition(s):
Intervention(s):
- Drug: nitazoxanide
- Procedure: pegylated interferon
- Behavior: ribavirin
Phase:
Phase 2Eligibility
Ages Eligible for Study:
Any Age 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:
Age ??18 years.
2. Chronic hepatitis C infection (at least 6 months) evidenced by a positive enzyme immunoassay (EIA) for anti-HCV-antibodies and a positive quantitative RT-PCR
amplification of HCV RNA.
3. Chronic liver disease consistent with chronic hepatitis C as documented by liver biopsy within 36 months prior to enrollment.
4. HCV genotype 1.
Key Exclusion Criteria:
Patients that have previously received treatment with any interferon (including peginterferon, albuferon, etc.) or any interferon-based treatment regimen for chronic hepatitis C.
2. Patients unable to take oral medications.
3. Use of herbal preparations (e.g., milk thistle, licorice, etc.) within 30 days prior to enrollment.
4. Females of child-bearing age who are either pregnant, breast-feeding or not using birth control and are sexually active. Female patients of child-bearing potential that are sexually active must have a baseline pregnancy test and must agree to continue two
acceptable methods of birth control for the duration of the study and for 6 months posttreatment.
A double barrier method, oral birth control pills administered for at least 2 monthly cycles prior to study drug administration, an IUD, or medroxyprogesterone acetate administered intramuscularly for a minimum of one month prior to study drug administration are acceptable methods of birth control for inclusion into the study.
5. Males whose female partners are either pregnant or of child-bearing potential or not using birth control and are sexually active. Male patients with female partners of childbearing potential may be enrolled if they are advised of the teratogenic/embryocidal
risks associated with ribavirin and if they agree to practice effective contraception using two effective forms of birth control during ribavirin therapy and for 6 months thereafter. Male patients must use a condom with spermicide as one of the two forms.
6. Any investigational drug therapy within 30 days prior to enrollment.
7. Patients with other causes of liver disease including autoimmune hepatitis.
8. Transplant recipients receiving immune suppression therapy.
9. Patients with screening tests positive for anti-HAV IgM Ab, HBsAg, anti-HBc IgM Ab or anti-HIV Ab.
10. Patients with decompensated cirrhosis, history of variceal bleeding, ascites, hepatic encephalopathy, CTP score >6 or MELD score >8.
11. Patients with an alcohol consumption of >40 g per day, or if in the opinion of the investigator, an alcohol use pattern that will interfere with the study.
12. Patients with absolute neutrophil count (ANC) <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).
13. Patients with either hypothyroidism or hyperthyroidism not effectively treated with medication. [Any patient with previously undiagnosed thyroid disease picked up at screening must be medically evaluated and excluded until a diagnosis is made and is stable on appropriate therapy for at least six months.].
14. Patients with HgbA1c > 7.5 or with a history of diabetes mellitus.
15. Patients with body mass index >34.
16. Patients with a history or other clinical evidence of significant or unstable cardiac disease (e.g., angina, congestive heart failure, hypertensive and not on a stable effective treatment regimen, significant arrhythmia).
17. Patients with a history or other clinical evidence of chronic pulmonary disease (e.g., chronic obstructive pulmonary disease) associated with functional impairment.
18. Patients with serious or severe bacterial infection(s).
19. Patients with ulcerative or hemorrhagic/ischemic colitis.
20. Patients with pancreatitis.
21. Patients with a history of severe or uncontrolled psychiatric disease, including severe depression, history of suicidal ideation, suicidal attempts or psychosis requiring medication and/or hospitalization.
22. Patients with a history of uncontrolled severe seizure disorder.
23. Patients requiring concomitant theophylline or methadone.
24. Patients with a history of immunologically mediated disease (e.g., rheumatoid arthritis, inflammatory bowel disease, severe psoriasis, systemic lupus erythematosus) requiring
more than intermittent nonsteroidal anti-inflammatory medications for management or that requires frequent or prolonged use of corticosteroids.
Additional Study Details
Official Title:
Phase II, Randomized, Double-Blind, Placebo-Controlled Study of Nitazoxanide in Combination with Peginterferon α-2a and Ribavirin in Treatment-Na?ve Patients with Hepatitis CAnticipated start date:
5/14/2008Lead Sponsor:
Romark Institute for Medical ResearchInvestigator(s):
Study Type:
InterventionalPurpose:
TreatmentAllocation:
RandomizedMasking:
Double BlindControl:
noneAssignment:
Single GroupEndpoints:
Safety/EfficacyPrimary Outcomes:
- Primary Efficacy Parameter: Sustained virologic response (HCV RNA below lower limit of
Secondary Outcomes:
- End of treatment response (HCV RNA below lower limit of detection at end of treatment)
- Early virologic response (HCV RNA below lower limit of
- Rapid virologic response (HCV RNA below lower limit of
- Change in HCV RNA during 4 week lead-in phase
- Change in ALT
Total Number to be Enrolled:
60Total Number to be Enrolled at Stanford:
0More Information
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:
5/4/2009PLEASE 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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