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Prospective Anti-Hepatitis C Virus (Anti-HCV) Trial of Peg-Interferon and Ribavirin in Subjects of First Nations, Metis and Caucasian Ethnicity (Praire)

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ClinicalTrials.gov Identifier: NCT00957866
Recruitment Status : Completed
First Posted : August 13, 2009
Last Update Posted : May 16, 2014
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Chronic Hepatitis C Drug: Pegylated Interferons (Peg-IFN) and Ribavirin Phase 4

Detailed Description:

Specific Objectives:

  1. To provide detailed information on the demographics and clinical characteristics of treatment-naïve FN and Metis versus non-FN and Non-Metis patients proceeding to treatment for CHC.
  2. To document and compare SVR and sustained biochemical response (SBR) rates, adherence to therapy, side effects, dose adjustments and discontinuation of treatment between FN and Metis and non-FN and Non-Metis patients.
  3. To determine whether the immunologic features associated with SVR (increased NK cell activity and enhanced interferon gamma production by CD4 cells in response to viral antigens) differ in FN and Metis and non-FN and non-Metis patients.
  4. To document and compare the direct costs of health care utilization and delivery for CHC between FN and Metis and non-FN and Non-Metis patients.
  5. Develop a model predicting outcome of therapy, using demographic, clinical and viral characteristics, and test the model with race as one of the explanatory variables.
  6. To forecast future prevalence, mortality and medical costs of CHC care in Canada.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Prospective Anti-HCV Trial of Peg-Interferon and Ribavirin in Subjects of First Nations, Metis and Caucasian Ethnicity: PRAIRIE Study
Study Start Date : May 2009
Primary Completion Date : October 2012
Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Drug: Pegylated Interferons (Peg-IFN) and Ribavirin
    A anti-viral regimen with a combination of pegylated Interferons (Peg-IFN) and Ribavirin

Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adult patients of FN and metis and non-FN descent referred for treatment at the three centres will be candidates for this study.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00957866


Locations
Canada, Manitoba
The University of Manitoba
Winnipeg, Manitoba, Canada, R3E 0W3
Canada, Saskatchewan
University of Regina
Regina, Saskatchewan, Canada
University of Saskatchewan
Saskatoon, Saskatchewan, Canada
Sponsors and Collaborators
University of Manitoba
Roche Pharma AG
Investigators
Principal Investigator: Minuk Gerald, MD University of Manitoba, Health Science senter
More Information

Responsible Party: Minuk G, Head of department, Section of Hepatology, Health Sciences Centre, John Bhuler Centre.
ClinicalTrials.gov Identifier: NCT00957866     History of Changes
Other Study ID Numbers: B2008:164
First Posted: August 13, 2009    Key Record Dates
Last Update Posted: May 16, 2014
Last Verified: May 2014

Keywords provided by University of Manitoba:
The number of cases in the database thus far (4,477) is clearly sufficient to achieve meaningful results

Additional relevant MeSH terms:
Hepatitis
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Interferons
Ribavirin
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action