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

NCT00957866 | Completed Phase 4 DMC

• 1 other identifier: B2008:164
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 3

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.

Conditions

Chronic Hepatitis C

Keywords

The number of cases in the database thus far (4,477) is clearly sufficient to achieve meaningful results

Outcome Measures

Primary Outcomes (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.

  3years

Interventions

Pegylated Interferons (Peg-IFN) and Ribavirin DRUG

A anti-viral regimen with a combination of pegylated Interferons (Peg-IFN) and Ribavirin

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• University of Manitoba: lead
• Roche Pharma AG: collaborator

Study Sites (3)

The University of Manitoba

Winnipeg, Manitoba, R3E 0W3, Canada

Location

University of Regina

Regina, Saskatchewan, Canada

Location

University of Saskatchewan

Saskatoon, Saskatchewan, Canada

Location

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

Ribavirin

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Minuk Gerald, MD

  University of Manitoba, Health Science senter

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 12, 2009
• First Posted: August 13, 2009
• Study Start: May 1, 2009
• Primary Completion: October 1, 2012
• Study Completion: November 1, 2012
• Last Updated: May 16, 2014

Record last verified: 2014-05

Locations

CA (3)