Chronic Hepatitis CPhase 4PraireNCT00957866
Prospective Anti-Hepatitis C Virus (Anti-HCV) Trial of Peg-Interferon and Ribavirin in Subjects of First Nations, Metis and Caucasian Ethnicity
A Phase 4 study testing Pegylated Interferons (Peg-IFN) and Ribavirin in people with Chronic Hepatitis C, run by University of Manitoba at 3 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Chronic Hepatitis C
- What is being tested?
- Pegylated Interferons (Peg-IFN) and Ribavirin
- How many people
- 160 participants
- Where
- 3 sitesCanada
- Study dates
- May 2009to Nov 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Adult patients of FN and metis and non-FN descent referred for treatment at the three centres will be candidates for this study.
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
University of Regina
Regina, Saskatchewan
University of Saskatchewan
Saskatoon, Saskatchewan
The University of Manitoba
Winnipeg, Manitoba, R3E 0W3
About this study
Official title: Prospective Anti-HCV Trial of Peg-Interferon and Ribavirin in Subjects of First Nations, Metis and Caucasian Ethnicity: PRAIRIE Study
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.
Read more
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.
Read the detailed description
Specific Objectives:
- 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.
- 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.
- 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.
- 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.
- 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.
- To forecast future prevalence, mortality and medical costs of CHC care in Canada.
- Conditions
- Chronic Hepatitis C
- Being tested
- Pegylated Interferons (Peg-IFN) and Ribavirin
- Keywords
- The number of cases in the database thus far (4,477) is clearly sufficient to achieve meaningful results
- Medical subject headings
- Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pegylated Interferons (Peg-IFN) and RibavirinDrug
A anti-viral regimen with a combination of pegylated Interferons (Peg-IFN) and Ribavirin
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2009 (estimated)
- Study startMay 2009
- Primary completionOct 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis CStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Pharma AG
- Investigators
- Minuk Gerald, MD, Principal investigator, University of Manitoba, Health Science senter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00957866
- Sponsor's protocol ID
- B2008:164
- Acronym
- Praire
- Status last verified
- May 2014
- First submitted
- 12 Aug 2009
- Last updated
- 16 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Anti-HCV Trial of Peg-Interferon and Ribavirin in Subjects of First Nations, Metis and Caucasian Ethnicity: PRAIRIE Study
- ClinicalTrials.gov ID
- NCT00957866
- Acronym / sponsor ID
- Praire / B2008:164
- Conditions
- Chronic Hepatitis C
- Keywords
- The number of cases in the database thus far (4,477) is clearly sufficient to achieve meaningful results
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Roche Pharma AG
- Study start
- May 2009
- Primary completion
- Oct 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 13 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Specific Objectives:
- 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.
- 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.
- 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.
- 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.
- 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.
- To forecast future prevalence, mortality and medical costs of CHC care in Canada.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients of FN and metis and non-FN descent referred for treatment at the three centres will be candidates for this study.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pegylated Interferons (Peg-IFN) and RibavirinA anti-viral regimen with a combination of pegylated Interferons (Peg-IFN) and Ribavirin | Drug | – |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Minuk Gerald, MD principal investigator
University of Manitoba, Health Science senter
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pegylated Interferons (Peg-IFN) and Ribavirin in people with Chronic Hepatitis C, run by University of Manitoba at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2014.