NCT00724451

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

Prospective, Observational, Multicentre Study Evaluating HCV Patients Characteristics of Eligibility and Disease Management in Real Clinical Practice

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,128 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Probability sampling: Consecutive adult patients with chronic hepatitis C in clinical practice at approximately 54 sites in Italy will be included in the study. The decision as to treatment choice falls at the discretion of the treating physician.

Conditions

• Hepatitis C
• Hepatitis C, Chronic

Interventions

Type	Name	Description
BIOLOGICAL	Peginterferon alfa-2b	Peginterferon alfa-2b administered in accordance with approved labeling
DRUG	Ribavirin	Ribavirin administered in accordance with approved labeling
BIOLOGICAL	Peginterferon alfa-2a	Peginterferon alfa-2a administered in accordance with approved labeling

Timeline

• Start date: 2008-07-01
• Primary completion: 2011-10-01
• Completion: 2011-10-01
• First posted: 2008-07-29
• Last updated: 2015-09-25
• Results posted: 2012-10-31