APPROACH Study: Quality of Life and Outcomes Assessment in Participants With Chronic Hepatitis C (CHC) Treated With Pegylated Interferon (PEG-IFN) Alfa-2a and Ribavirin
NCT ID: NCT02850289
Last Updated: 2017-10-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
385 participants
OBSERVATIONAL
2006-04-30
2008-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Pegylated Interferon (PEG-IFN) alfa-2a and Ribavirin
Participants with hepatitis C who were to be treated with combination of pegylated interferon (PEG-IFN) alfa-2a and ribavirin, within 7 days of baseline, with ongoing management at investigator's discretion.
Pegylated interferon (PEG-INF) alfa-2a
Pegylated interferon (PEG-IFN) alfa-2a will be administered as per investigator's discretion and will be in line with the current product monograph.
Ribavirin
Ribavirin will be administered as per investigator's discretion and will be in line with the current product monograph.
Interventions
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Pegylated interferon (PEG-INF) alfa-2a
Pegylated interferon (PEG-IFN) alfa-2a will be administered as per investigator's discretion and will be in line with the current product monograph.
Ribavirin
Ribavirin will be administered as per investigator's discretion and will be in line with the current product monograph.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Serologic evidence of chronic hepatitis C (CHC) infection
* Detectable serum hepatitis C virus - ribonucleic acid (HCV-RNA)
* Negative urine or blood pregnancy test
* Fertile participants receiving treatment to use two forms of effective contraception during treatment and for 6 months after treatment end
Exclusion Criteria
* Received any investigational drug less than or equal to (\</=) 6 weeks prior to enrollment
* Moderate hepatic failure \[Child-Pugh greater than or equal to (\>/=) B\]
* Co-infection with human immunodeficiency virus (HIV) or hepatitis B
* Autoimmune hepatitis
* Known hypersensitivity to alfa interferons, E. coli-derived products, polyethylene glycol, ribavirin and/or any ingredient in the formulation or component of PEG-IFN alfa-2a or ribavirin
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Calgary, Alberta, Canada
Edmonton, Alberta, Canada
Edmonton, Alberta, Canada
Edmonton, Alberta, Canada
Abbotsford, British Columbia, Canada
Surrey, British Columbia, Canada
Vancouver, British Columbia, Canada
Vancouver, British Columbia, Canada
Vancouver, British Columbia, Canada
Vancouver, British Columbia, Canada
Vernon, British Columbia, Canada
West Vancouver, British Columbia, Canada
Winnipeg, Manitoba, Canada
Barrie, Ontario, Canada
Brampton, Ontario, Canada
Downsview, Ontario, Canada
Greater Sudbury, Ontario, Canada
Hamilton, Ontario, Canada
Kingston, Ontario, Canada
London, Ontario, Canada
London, Ontario, Canada
London, Ontario, Canada
Mississauga, Ontario, Canada
Newmarket, Ontario, Canada
Oshawa, Ontario, Canada
Oshawa, Ontario, Canada
Ottawa, Ontario, Canada
Ottawa, Ontario, Canada
Richmond Hill, Ontario, Canada
Richmond Hill, Ontario, Canada
Thunder Bay, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Windsor, Ontario, Canada
Windsor, Ontario, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Québec, Quebec, Canada
Québec, Quebec, Canada
Québec, Quebec, Canada
Québec, Quebec, Canada
Saint-Charles-Borromée, Quebec, Canada
Regina, Saskatchewan, Canada
Saskatoon, Saskatchewan, Canada
Countries
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Other Identifiers
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ML20090
Identifier Type: -
Identifier Source: org_study_id