Status:
COMPLETED
Pegylated Interferon Plus Ribavirin in the Treatment of Active and Past Intravenous Drug Users Infected With Hepatitis C
Lead Sponsor:
University of Calgary
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Roche Pharma AG
Conditions:
Hepatitis c
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 comm...
Detailed Description
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. Our goal is to determine whether ...
Eligibility Criteria
Inclusion
- Men or women age 18 to 75 years.
- Chronic hepatitis C infection based on a history of positive anti-HCV antibody and/or HCV RNA at least 6 months prior to study entry.
- Positive HCV-RNA by Roche Amplicor HCV test at screening
- Serum ALT \> 1.5 times upper limit of normal
- Active or past use of injection drugs or crack cocaine by self-report. Active use is defined as injection drug use at least 1/month and within 3 months of the date of randomization. Past use is defined as no injection drug use or crack cocaine use within the past 5 years.
- Compensated liver disease
- Negative urine or blood pregnancy tests (for women of childbearing potential) documented within 24-hours prior to first dose of study drug.
- All fertile males and females must use effective contraception during treatment and during the 6 months after treatment end if sexually active (This will be provided free of charge to active IDUs).
Exclusion
- 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.
- Platelet count \< 60,000/mm3
- Serum ALT level \> 10 times upper limit of normal
- Serum creatinine level \> 1.5 times the upper limit of normal (Deleted February 27, 2007, Protocol Amendment #4, Ethics approval March 28, 2007)
- 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)
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT00203606
Start Date
January 1 2004
End Date
August 1 2011
Last Update
August 4 2011
Active Locations (2)
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1
University of Calgary
Calgary, Alberta, Canada, T2N4N1
2
Pender Clinic
Vancouver, British Columbia, Canada