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Sponsors and Collaborators: |
University of Calgary Canadian Institutes of Health Research (CIHR) Hoffmann-La Roche |
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Information provided by: | University of Calgary |
ClinicalTrials.gov Identifier: | NCT00203606 |
Hepatitis C infects as many as 300,000 Canadians. Up to 25% of those infected will develop cirrhosis and be at risk for liver failure and liver cancer. Cirrhosis caused by hepatitis C is the most common reason for liver transplantation in Canada. The largest group of infected people are those who use injectable street drugs.
However, people who continue to use drugs are routinely excluded from scientific studies testing new treatments for Hepatitis C and are generally recommended not to receive available treatments. Although several reasons are given to justify excluding these people from treatment, little scientific evidence is available to support it. We plan to examine how successful treatment with the current standard treatment of pegylated interferon and ribavirin is in those who continue to use injection drugs. We will compare the results of treatment of 70 active drug users to 70 reformed drug users. Our goal is to determine whether reasonable success rates can be achieved in active drug users that would then further justify their routine treatment.
Condition | Intervention | Phase |
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Hepatitis C |
Drug: pegylated interferon alfa-2a ( Roche) and ribavirin |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment |
Official Title: | Effectiveness of Pegylated Interferon Plus Ribavirin in the Treatment of Active and Past Intravenous Drug Users Infected With Hepatitis C |
Enrollment: | 70 |
Study Start Date: | January 2004 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: pegylated interferon alfa-2a ( Roche) and ribavirin
pegylated interferon alfa-2a ( Roche) and ribavirin
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2: No Intervention |
We plan to examine how successful treatment with the current standard treatment of pegylated interferon and ribavirin is in those who continue to use injection drugs. We will compare the results of treatment of 70 active drug users to 70 reformed drug users. Our goal is to determine whether reasonable success rates can be achieved in active drug users that would then further justify their routine treatment.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
1. Presence of clinically evident ascites requiring active diuretic therapy, history of or therapy for hepatic encephalopathy, or history of variceal bleeding within the last two years. 2. Platelet count < 60,000/mm3 3. Serum ALT level > 10 times upper limit of normal 4. Serum creatinine level > 1.5 times the upper limit of normal 5. Hematology outside of specified limits: neutrophil count < 1000/mm3, hemoglobin < 10 g/L in males and < 9 g/L in females 7. Unstable or uncontrolled thyroid disease 8. Treatment with interferon- and/or ribavirin within the previous 12 months 9. Presence of clinically significant cryoglobulinemia vasculitis (e.g. skin rash, arthritis, or renal insufficiency due to cryoglobulinemia) 10. Presence or history of autoimmune hepatitis, alpha-1-anti-trypsin deficiency, genetic hemochromatosis, Wilson disease, drug- or toxin-induced liver disease, alcohol-related liver disease, primary biliary cirrhosis, or sclerosing cholangitis. 11. Chronic hepatitis B infection or positive HbsAg at screening 12. Known history of HIV infection or positive HIV antibody test by Western Blot.
13. A disease known to cause significant alteration in immunologic function, including hematological malignancy or autoimmune disorder. 14. Concurrent therapy with immunosuppressive drugs or cytotoxic agents, such as prednisone, cyclosporine, azathioprine or chemotherapeutic agents. 15. History of unstable or deteriorating cardiac, pulmonary or renal disease. 16. Preexisting (within last two years) or active psychiatric condition including severe untreated depression, major psychoses, suicidal ideation or suicidal attempts. 17. Severe or poorly controlled diabetes mellitus 18. Any serious or chronic disease that may affect the assessment of safety or efficacy parameters.
19. Patients who have had a liver transplant 20. Patients infected with HCV genotypes 4, 5 or 6 (< 1% of infected current/past IDUs)
Canada, Alberta | |
University of Calgary | |
Calgary, Alberta, Canada, T2N4N1 |
Principal Investigator: | Robert J Hilsden, MD PhD | University of Calgary |
Responsible Party: | University of Calgary ( Robert Hilsden ) |
Study ID Numbers: | 21995 |
Study First Received: | September 13, 2005 |
Last Updated: | June 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00203606 History of Changes |
Health Authority: | Canada: Health Canada |
Antimetabolites Interferon-alpha Anti-Infective Agents Liver Diseases Immunologic Factors Ribavirin Interferons Hepatitis, Viral, Human |
Angiogenesis Inhibitors Antiviral Agents Hepatitis Virus Diseases Digestive System Diseases Peginterferon alfa-2a Hepatitis C Interferon Alfa-2a |
Antimetabolites Anti-Infective Agents Liver Diseases Molecular Mechanisms of Pharmacological Action Flaviviridae Infections Immunologic Factors Antineoplastic Agents Ribavirin Physiological Effects of Drugs Hepatitis, Viral, Human Therapeutic Uses Hepatitis C Angiogenesis Modulating Agents |
Growth Inhibitors Interferon-alpha RNA Virus Infections Growth Substances Interferons Antiviral Agents Angiogenesis Inhibitors Pharmacologic Actions Virus Diseases Hepatitis Digestive System Diseases Peginterferon alfa-2a Interferon Alfa-2a |