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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

NCT02850289

CompletedN/A

Sponsor: Hoffmann-La Roche

Conditions: Hepatitis C, Chronic

Interventions: Pegylated interferon (PEG-INF) alfa-2a, Ribavirin

Countries: Canada

This multi-center, observational study will examine the clinical use and outcomes of pegylated interferon (PEG-IFN) alfa-2a and ribavirin combination (PEGASYS RBV) in participants with chronic hepatitis C (CHC). Study visits will be scheduled for baseline, 12, 24 and 48 weeks after baseline. An additional follow-up visit at week 72 will be required for participants with an HCV genotype other than 2 or 3. Quality of life data will be collected at baseline, and at each follow-up visit.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

* Eligible for and scheduled to receive treatment with commercially available PEG-IFN alfa-2a and ribavirin combination
* 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:

* Women with ongoing pregnancy or who are breast feeding, or male partners of women who are pregnant
* 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

Locations (46)

Calgary, Alberta, Canada
Edmonton, Alberta, Canada
Edmonton, Alberta, Canada
Edmonton, Alberta, Canada
Abbotsford British Columbia, 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
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