Observational Study Assessing Chronic Hepatitis C Management in Clinical Practice in Italy (Study P05488 AM1)

• Status: Completed
• Trial end date: 2011-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this study is to elucidate the reasons why patients with chronic hepatitis C (CHC) would not be considered eligible for antiviral treatment. The study is conducted in common clinical practice at approximately 54 sites in Italy. Patients deemed eligible for antiviral therapy will be treated at the discretion of the physician with either peginterferon alfa-2a or peginterferon alfa-2b, both in combination with ribavirin, in accordance with approved labeling. A secondary objective of this study is to define "treatment failure" and to evaluate the reasons for treatment discontinuation.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Interferon-alpha; Peginterferon alfa-2a; Peginterferon alfa-2b; Ribavirin

Criteria

Inclusion Criteria:

• Willingness to sign an Informed Consent

• Male and female patients >=18 years of age with Chronic Hepatitis C

• Not previously treated with Peg-Interferons

• Positive for serum hepatitis C virus (HCV)-ribonucleic acid (RNA)

Exclusion Criteria:

• Previous treatment with peginterferon

• Participation in a therapeutic Good Clinical Practice (GCP) clinical study within 30 days prior to study start