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

• Status: Completed
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Interferons; Peginterferon alfa-2a; Ribavirin

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 (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