A Phase 4 interventional study of Pegylated Interferons (Peg-IFN) and Ribavirin in Chronic Hepatitis C, sponsored by University of Manitoba. Completed at 3 sites in Canada. Per ClinicalTrials.gov, last updated 2014-05-16.
Sponsored by University of Manitoba · Phase 4, Interventional, and Supportive care
Background:
According to recent estimates, the prevalence of Chronic Hepatitis C (CHC) in Canada is three times more common in First Nations (FN)and Metis compared to non-FN populations. Moreover, once infected, the progression of CHC to cirrhosis and/or hepatocellular carcinoma is greater in FN patients due to the increased prevalence of alcohol abuse, obesity and diabetes in this segment of the population.
Research Plan:
This research proposal consists of three parts. The objective of Part I is to document the response to anti-viral treatment for CHC among treatment-naïve FN and Metis and Caucasian (hereafter referred to as non-FN) patients residing in three urban Western Canadian centres (Winnipeg, Saskatoon and Regina). Demographic, clinical and response to treatment data in a total of 160 patients (80/group) will be collected at the above centres and transferred to the Section of Hepatology at the University of Manitoba for statistical analyses. In Part II, the applicants will document and compare the immune responses to HCV proteins throughout the course of therapy in FN, Metis and non-FN patients. In the final part, direct economic costs of CHC care in FN, Metis and non-FN patients will be ascertained and future costs predicted.
Hypotheses:
Part I - The rate of sustained virologic response (SVR) to treatment for CHC is higher in FN and Metis compared to non-FN and no Metis patients.
Part II - The immune response to HCV proteins during anti-viral therapy for CHC is enhanced in FN and Metis compared to non-FN and non-Metis patients.
Part III - The direct costs of health care utilization and delivery for CHC are similar among FN and Metis and non-FN and non- Metis patients.
Specific Objectives:
2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.
This study's planned enrollment of 160 is above the median of 100 across 1,886 interventional studies indexed under Hepatitis A.
Browse Hepatitis A studies →University of Manitoba is the lead sponsor of 542 studies on the registry; 87 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 5 (42%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
A anti-viral regimen with a combination of pegylated Interferons (Peg-IFN) and Ribavirin
SVR is the primary outcome for this study. SVR is defined as a negative serum HCV-RNA by a qualitative test sensitive to <50 IU/ml six months after the completion of therapy14, performed by a Health Canada approved laboratory.
Time frame: 3years
This study is completed, as verified in May 2014. You cannot join it, but the record below documents what was studied.
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University of Manitoba