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

Completed

• Conditions: Hepatitis C; Hepatitis C, Chronic
• Interventions: Biological: Peginterferon alfa-2b; Drug: Ribavirin; Biological: Peginterferon alfa-2a

• Registration Number: NCT00724451
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief 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.

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-07-25
• Study First Submitted QC: 2008-07-25
• Study First Posted: 2008-07-29
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Results First Submitted: 2012-10-05
• Results First Submitted QC: 2012-10-05
• Results First Posted: 2012-10-31
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-24
• Last Update Posted: 2015-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1128

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants with Chronic Hepatitis C (CHC)	Peginterferon alfa-2b	Peginterferon-naïve participants with CHC seen in general clinical practice in Italy and treated with either pegylated interferon alfa-2a or alfa-2b + ribavirin.
Participants with Chronic Hepatitis C (CHC)	Ribavirin	Peginterferon-naïve participants with CHC seen in general clinical practice in Italy and treated with either pegylated interferon alfa-2a or alfa-2b + ribavirin.
Participants with Chronic Hepatitis C (CHC)	Peginterferon alfa-2a	Peginterferon-naïve participants with CHC seen in general clinical practice in Italy and treated with either pegylated interferon alfa-2a or alfa-2b + ribavirin.

Primary Outcome Measures

Name	Time	Method
Number of Participants Not Eligible for Antiviral Treatment by Reason for Non-eligibility	Measured at baseline	Investigators recorded their reasons for not prescribing anti-viral treatment. More than one reason leading to non-eligibility could be presented for the same participant.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Discontinued From Treatment by Reason for Discontinuation	24 weeks after the end of treatment (total of 48 to 72 weeks)	Investigators recorded reasons for treatment discontinuation.
Number of Participants With Treatment Failure by Reason for Failure	24 to 48 weeks	Investigators recorded reasons for treatment failure whether or not treatment was completed.