NCT00399672|Completed
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Sponsor study identifier
interventional
370
1 country
1
Study Start
June 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2010
Actual (reported)Study Completion
December 2012
Actual (reported)Although injection drug users (IDUs) account for over 70% of new cases of HCV infection/year, there is no consensus on how to approach their medical care. In some Canadian centres, patients must be free of recreational drug use for as long as 6 months before being considered for HCV therapy. This is not consistent with current North American guidelines. Over the past 5 years, we have developed a successful program for the treatment of HIV infection in this population, based on a multi-disciplinary comprehensive program including directly observed therapy (DOT). Even though the duration of therapy for HCV is shorter than for HIV (as little as 6 months vs. life-long), we must address issues of administration of a weekly injection (interferon), twice daily pills (ribavirin) and the risk of significant side effects (including anxiety and depression) to successfully expand our program to treat this disease. Further, it may be that even if the program is successful, its benefits will be negated by HCV re-infection due to continued risk behaviors for its transmission.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2012
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 14, 2006
Actual (reported)November 15, 2006
Actual (reported)June 2007
Date type not reportedThis date has not been verified as actual or estimated.
August 2010
Actual (reported)December 2012
Actual (reported)Rate of sustained virologic response (SVR) six months after completion of treatment.
Adherence to therapy
Cost
Quality of life
The 4 participating sites are designated either High Intensity or Low Intensity. High Intensity sites have access to: full time specialist physicians, access to full time nurses and counselors. All weekly pegylated interferon injections will be administered by clinic staff and ribavirin will be dispensed in weekly medication pack.
The 4 participating sites are designated either High Intensity or Low Intensity. In the Low intensity group, all patients will have access to: full time primary care physicians, specialist physicians and access to part time nurse or counselor by appointment. Patients will be offered the option of self or nurse administered pegylated interferon injections on an appointment basis. Ribavirin will be dispensed biweekly. The treatment medication cannot be stored at the clinic; it must be the subjects responsibility.
Weekly pegylated interferon injections will be administered by clinic staff and ribavirin will be dispensed in weekly medication pack.
Patients will be offered the option of self or nurse administered pegylated interferon injections on an appointment basis. Ribavirin will be dispensed biweekly. The treatment medication cannot be stored at the clinic; it must be the subjects responsibility.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Interferon injections and ribavirin
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordGrouped treatment entry
Interferon injections and ribavirin
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordPender Community Health Centre
Vancouver, British Columbia, V6B 1R3, Canada
Brian Conway, MD
University of British Columbia
370 participants (actual enrollment reported by the registry).
First Submitted
November 14, 2006
First Posted
November 15, 2006
Study Start
June 2007
Date type not reportedThis date has not been verified as actual or estimated.
Integrating Hepatitis C Screening With Dried Blood Spot Testing Into Colorectal Cancer Screening
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
August 2010
Actual (reported)Study Completion
December 2012
Actual (reported)Last Updated
November 30, 2016
Record last verified: 2016-11
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Source: ClinicalTrials.gov.
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