Phase 2
Completed N=64
Study of Nitazoxanide, Peginterferon Alfa-2a and Ribavirin for the Treatment of Hepatitis C
Chronic Hepatitis C
Source: ClinicalTrials.gov NCT00495391 ↗
Enrolled (actual)
64
Serious AEs
3.1%
Results posted
Jan 2014
Primary outcomePrimary: Sustained Virologic Response (HCV RNA Below Lower Limit of Detection) — 3; 0; 39; 22 participants
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 patients that have previously failed to respond to treatment with peginterferon and ribavirin.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sustained Virologic Response (HCV RNA Below Lower Limit of Detection) |
3; 0; 39; 22 | — |
| SECONDARY End of Treatment Response (HCV RNA Below Lower Limit of Detection) |
6; 1; 36; 21 | — |
| SECONDARY Early Virologic Response (HCV RNA Below Lower Limit of Detection) |
3; 0; 39; 22 | — |
| SECONDARY Rapid Virologic Response (HCV RNA Below Lower Limit of Detection) |
2; 0; 40; 22 | — |
| SECONDARY Changes in ALT |
0; 0; 1; 0; 4; 1 | — |
| SECONDARY Changes in ALT |
0; 0; 1; 0; 4; 1 | — |
| SECONDARY Changes in ALT |
0; 0; 1; 0; 4; 1 | — |
| SECONDARY Changes in ALT |
0; 0; 1; 0; 4; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Chronic hepatitis C genotype 1.
- Failed to respond to ≥12 weeks of peginterferon and ribavirin ( 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 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.
Data sourced from ClinicalTrials.gov (NCT00495391). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.