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

Merck Sharp & Dohme (MSD)

Status: Completed

Conditions: Hepatitis C, Chronic; Hepatitis C

Treatments: Drug: Ribavirin; Biological: Peginterferon alfa-2a; Biological: Peginterferon alfa-2b

Study type: Observational

Funder types: Industry

Identifiers

NCT00724451

P05488

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,128 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

1,128 participants in 1 patient group

Participants with Chronic Hepatitis C (CHC)

Description:

Peginterferon-naïve participants with CHC seen in general clinical practice in Italy and treated with either pegylated interferon alfa-2a or alfa-2b + ribavirin.

Treatment:

Biological: Peginterferon alfa-2b

Biological: Peginterferon alfa-2a

Drug: Ribavirin