Study of Nitazoxanide, Peginterferon Alfa-2a and Ribavirin for the Treatment of Hepatitis C (STEALTHC-2)
This study has been completed.
Sponsor:
Romark Laboratories L.C.
Information provided by (Responsible Party):
Romark Laboratories L.C.
ClinicalTrials.gov Identifier:
NCT00495391
First received: July 2, 2007
Last updated: May 30, 2012
Last verified: May 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Hepatitis C |
Drug: Nitazoxanide Drug: Placebo Biological: Peginterferon alfa-2a Drug: Ribavirin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 Ribavirin |
Resource links provided by NLM:
Further study details as provided by Romark Laboratories L.C.:
Primary Outcome Measures:
- Sustained virologic response (HCV RNA below lower limit of detection) [ Time Frame: 24 weeks after end of treatment ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- End of treatment response (HCV RNA below lower limit of detection) [ Time Frame: At end of treatment ] [ Designated as safety issue: No ]
- Early virologic response (HCV RNA below lower limit of detection) [ Time Frame: After 12 weeks combination treatment ] [ Designated as safety issue: No ]
- Rapid virologic response (HCV RNA below lower limit of detection) [ Time Frame: After 4 weeks combination treatment ] [ Designated as safety issue: No ]
- Changes in ALT [ Time Frame: From baseline to weeks 8, 16, end of treatment and end of follow-up ] [ Designated as safety issue: No ]
| Enrollment: | 64 |
| Study Start Date: | July 2007 |
| Study Completion Date: | February 2010 |
| Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Oral 500 mg nitazoxanide twice daily for 4 weeks followed by oral 500 mg nitazoxanide twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.
|
Drug: Nitazoxanide
One oral 500 mg nitazoxanide tablet twice daily for 52 weeks.
Other Name: Alinia
Biological: Peginterferon alfa-2a
Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.
Other Name: PEGASYS
Drug: Ribavirin
1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.
Other Name: COPEGUS
|
|
Placebo Comparator: 2
Oral placebo twice daily for 4 weeks followed by oral placebo twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.
|
Drug: Placebo
One oral placebo tablet twice daily for 52 weeks.
Biological: Peginterferon alfa-2a
Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.
Other Name: PEGASYS
Drug: Ribavirin
1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.
Other Name: COPEGUS
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Chronic hepatitis C genotype 1.
- 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).
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 >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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00495391
Locations
| United States, California | |
| VA Palo Alto Healthcare System | |
| Palo Alto, California, United States, 94304 | |
| Stanford University School of Medicine | |
| Stanford, California, United States, 94305 | |
| United States, Connecticut | |
| Yale University Digestive Diseases | |
| New Haven, Connecticut, United States, 06520 | |
| United States, Florida | |
| University of Florida Hepatology | |
| Gainesville, Florida, United States, 32610 | |
| Florida Center for Gastroenterology | |
| Largo, Florida, United States, 33777 | |
| United States, Georgia | |
| Atlanta Gastroenterology Associates | |
| Atlanta, Georgia, United States, 30308 | |
| United States, New York | |
| Weill Cornell Medical College | |
| New York, New York, United States, 10021 | |
| United States, Tennessee | |
| Nashville Medical Research Institute | |
| Nashville, Tennessee, United States, 37205 | |
| United States, Texas | |
| Brooke Army Medical Center | |
| Fort Sam Houston, Texas, United States, 78234 | |
| United States, Virginia | |
| McGuire VA Medical Center | |
| Richmond, Virginia, United States, 23249 | |
Sponsors and Collaborators
Romark Laboratories L.C.
Investigators
| Principal Investigator: | David Nelson, MD | University of Florida Hepatology |
| Principal Investigator: | Stephen Harrison, MD | Brooke Army Medical Center |
| Principal Investigator: | Arthur Berman, DO | Florida Center for Gastroenterology |
| Principal Investigator: | Ronald Pruitt, MD | Nashville Medical Research Institute |
| Principal Investigator: | Ahmed Aijaz, MD | Stanford University |
| Principal Investigator: | Ramsey Cheung, MD | VA Palo Alto Healthcare System |
| Principal Investigator: | Ira Jacobson, MD | Weill Medical College of Cornell University |
| Principal Investigator: | Mitchell Shiffman, MD | McGuire VA Medical Center |
| Principal Investigator: | Joseph Lim, MD | Yale University Digestive Diseases |
| Principal Investigator: | Norman Gitlin, MD | Atlanta Gastroenterology Associates |
More Information
No publications provided
| Responsible Party: | Romark Laboratories L.C. |
| ClinicalTrials.gov Identifier: | NCT00495391 History of Changes |
| Other Study ID Numbers: | RM01-2025 |
| Study First Received: | July 2, 2007 |
| Last Updated: | May 30, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Romark Laboratories L.C.:
|
Hepatitis C, Chronic |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis, Chronic Hepatitis C Hepatitis C, Chronic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Flaviviridae Infections |
Ribavirin Peginterferon alfa-2a Interferon-alpha Nitazoxanide Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antimetabolites Molecular Mechanisms of Pharmacological Action Antiparasitic Agents Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 22, 2013