Hepatitis C, Chronic
Conditions
Brief summary
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.
Interventions
DRUGPegylated 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.
DRUGRibavirin
Ribavirin will be administered as per investigator's discretion and will be in line with the current product monograph.
Sponsors
Hoffmann-La Roche
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants with Sustained Virologic Response (SVR) | Up to Week 72 |
Secondary
| Measure | Time frame |
|---|---|
| Short Form Health Survey (SF-36) Physical Composite Score | Baseline, Week 12, 24, 48 and 72 |
| Short Form Health Survey (SF-36) Mental Composite Score | Baseline, Week 12, 24, 48 and 72 |
| Percentage of Participants with Adverse Events of Special Interest Leading to Study Medication Discontinuation | Up to Week 72 |
| Percentage of Participants Who Utilized Resources | Baseline, Week 12, 24, 48 and 72 |
Countries
Canada
Outcome results
None listed